ResMed AirSense S10 Clinical Manual Download Page 1

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Clinical guide

English

Clinical guide

Summary of Contents for AirSense S10

Page 1: ...Clinical guide English ...

Page 2: ...fort related arousals reporting 9 Comfort features 10 Ramp 10 Expiratory Pressure Relief 10 Climate Control 11 Climate Control Auto 11 Climate Control Manual 11 Tube Temperature 11 Humidity Level 11 Setup 12 Supplemental oxygen 13 Antibacterial filters 13 Accessing and exiting the Clinical Menu 14 Adjusting the clinical settings 14 Setting the date and time 15 Settings menu 15 Therapy 15 Comfort 1...

Page 3: ...ssembling 24 Decontaminating 25 High level thermal disinfection 25 Inspecting 25 Reassembling 26 Data management and therapy compliance 28 Remote monitoring 28 SD card 28 Data storage 29 Software upgrade 29 Managing patient care 30 Patient menu 30 Therapy data 30 Traveling 30 Traveling by plane 30 Troubleshooting 31 General troubleshooting 31 Device messages 33 Technical specifications 35 Symbols ...

Page 4: ...adjusting device is indicated for the treatment of obstructive sleep apnea OSA in patients female patients with mild to moderate OSA when using AutoSet for Her treatment mode weighing more than 66 lb 30 kg It is intended for home and hospital use The humidifier is intended for single patient use in the home environment and re use in a hospital institutional environment AirSense 10 Elite The AirSen...

Page 5: ... of the nose mouth or throat nosebleed bloating ear or sinus discomfort eye irritation skin rashes At a glance The AirSense 10 includes the following Device with HumidAir integrated humidifier Water tub Air tubing Power supply unit Travel bag SD card already inserted A range of accessories are available for use with the device including Air tubing heated and non heated ClimateLineAir SlimLine Stan...

Page 6: ... enter power save mode Dial Turn to navigate the menu and press to select an option Turn to adjust a selected option and press to save your change Home button Press to return to the Home screen Different icons may be displayed on the screen at different times including Ramp Time Wireless signal strength green Ramp Time Auto Wireless transfer not enabled gray Humidity 㘕 No No wireless connection Hu...

Page 7: ... mode the device provides only that amount of pressure required to maintain upper airway patency The device analyzes the state of the patient s upper airway on a breath by breath basis and delivers pressure within the allowed range according to the degree of obstruction The AutoSet algorithm adjusts treatment pressure as a function of three parameters inspiratory flow limitation snore and apnea No...

Page 8: ...traditional as well as less common flow limited breath wave forms Snore Snoring is sound generated by vibrations of the walls of the upper airway It is often preceded by flow limitation or a partial obstruction of the airway Apnea The enhanced AutoSet algorithm detects both obstructive and central apneas If an apnea occurs the device responds appropriately ...

Page 9: ...is no flow When a central apnea is detected the device responds appropriately by not increasing pressure AutoSet for Her mode AutoSet for Her mode is based on key aspects of ResMed s AutoSet algorithm and delivers therapeutic responses tailored to the characteristics of female OSA patients The AutoSet for Her is similar to ResMed s AutoSet algorithm with the following modifications Reduced rate of...

Page 10: ...al Sleep Apnoea Detection with Forced Oscillation Technique CPAP mode In CPAP mode a fixed pressure is delivered with optional Expiratory Pressure Relief EPR Reporting The AirSense 10 reports Respiratory Effort Related Arousals RERA and detects Central Sleep Apnea CSA and Cheyne Stokes Respiration CSR The summary and detailed data of these parameters are available to view on ResMed s patient compl...

Page 11: ...at the mask to measure the airway patency Cheyne Stokes respiration detection Available in all modes on the AirSense 10 AutoSet AirSense 10 AutoSet for Her and the AirSense 10 Elite Cheyne Stokes respiration CSR is a form of sleep disordered breathing characterized by a periodic waxing and waning of respiration The waxing periods hyperpneas typically 40 seconds in length can include large gasping ...

Page 12: ... hypopnea events calculates the time between these events and characterizes the shape of breathing between them Respiratory effort related arousals reporting Respiratory Effort Related Arousals RERA reporting is available on the AirSense 10 AutoSet for Her in all modes RERAs are periods of increasing respiratory effort which are terminated by an arousal Increasing respiratory effort will be seen a...

Page 13: ...se from the start pressure to the minimum treatment pressure at a rate of 1 cm H2O per minute However if sleep onset is not detected the device will reach the target pressure within 30 minutes Expiratory Pressure Relief Designed to make therapy more comfortable Expiratory Pressure Relief EPR maintains optimal treatment for the patient during inhalation and reduces the delivered mask pressure durin...

Page 14: ... tube temperature If the air temperature becomes too warm and rainout continues try decreasing the humidity Tube Temperature If the air in the mask feels too warm or too cold the patient can adjust the temperature to find what is most comfortable or turn it off completely The Tube Temperature can be set to anywhere between 60 86 F 16 30 C The temperature sensor located at the mask end of the Clima...

Page 15: ... into the power outlet 3 Connect the air tubing firmly to the air outlet located on the rear of the device 4 Open the water tub and fill it with distilled water up to the maximum water level mark Do not fill the water tub with hot water 5 Close the water tub and insert it into the side of the device 6 Connect the free end of the air tubing firmly onto the assembled mask See the mask user guide for...

Page 16: ...Adding oxygen may affect the delivered pressure and the accuracy of the displayed leak and minute ventilation Before adding oxygen familiarize yourself and your patient with the specific warnings relating to the use of supplemental oxygen These can be found at the end of this guide Antibacterial filters Antibacterial filters increase resistance in the air circuit and may affect accuracy of display...

Page 17: ...r of the screen To exit the Clinical Menu Press and hold the dial and the Home button for three seconds Select Exit Clinical Menu from the Home screen The device will automatically exit the Clinical Menu after 20 minutes of inactivity Adjusting the clinical settings 1 Access the Clinical Menu highlight Settings and press the dial The Settings menu is displayed 2 Turn the dial to highlight the sett...

Page 18: ... correct date 2 Select Time and change it to the correct local time 3 Make sure the correct local time and date has been applied The AirSense 10 settings must be configured for each individual patient The settings should be periodically reassessed to ensure optimal therapy Settings menu You set all parameters relating to a patient s therapy and device configuration in the Settings menu Therapy Par...

Page 19: ...e disable EPR On Off EPR Type Available when EPR is enabled Full Time Ramp Only EPR Level Set the EPR value 1 2 3 cm H2O Climate Ctrl Available when water tub is used and ClimateLineAir heated air tubing is connected Manual Auto Tube Temp Set the minimum temperature of air delivered by heated air tubing such as ClimateLineAir Off 60 86 F 16 30 C 1 increments Humidity Level Set the humidity level O...

Page 20: ...ion Selection Language Set the display language Not all languages available in all regions English Français Español Português Date Set the current date If you set a new date that occurs in the past then an error message is displayed Before this change can be made erase the compliance data available under the Configuration menu DD Mmm YYYY Time Set the current time If you set a new time that occurs...

Page 21: ...ss Home or the dial to turn it back on If power is interrupted during therapy the device will automatically restart therapy when power is restored The AirSense 10 device has a light sensor that adjusts the screen brightness based on the light in the room Stopping therapy 1 Direct the patient to remove the mask 2 Direct the patient to press Start Stop or if SmartStart is enabled therapy will stop a...

Page 22: ... Sleep Report The options are 1 Day 1 Week 1 Month 3 Months 6 Months 1 Year Days Used Number of days the device has been used during the selected period or since the last compliance data was reset Days 4hrs Number of days the device has been used for more than 4 hours during the selected period or since the last compliance data was reset Avg Usage Average number of hours per day the device has bee...

Page 23: ...evice weekly as described Refer to the mask user guide for detailed instructions on cleaning the mask 1 Wash the water tub and air tubing in warm water using mild detergent Do not wash in a dishwasher or washing machine 2 Rinse the water tub and air tubing thoroughly and allow to dry out of direct sunlight and or heat 3 Wipe the exterior of the device with a dry cloth Checking You should regularly...

Page 24: ... and then close it Make sure the air filter is fitted at all times to prevent water and dust from entering the device Reassembling When the water tub and air tubing are dry you can reassemble the parts 1 Connect the air tubing firmly to the air outlet located on the rear of the device 2 Open the water tub and fill it with distilled room temperature water up to the maximum water level mark 3 Close ...

Page 25: ...uide and their effect on the performance of the product will be acceptable When using detergents disinfectants or sterilization agents always follow the manufacturer s instructions Beware of electrocution Do not immerse the device power supply or power cord in water If liquids are spilled into or onto the device unplug the device and let the parts dry Always unplug the device before cleaning and m...

Page 26: ...ch component according to the detergent manufacturer s instructions ResMed has tested the following detergents according to the manufacturer s instructions Detergent Water temperature SlimLine ClimateLineAir Standard Alconox diluted at 1 Hot water approx 140 F or 60 C Warm water approx 113 to 140 F or 45 to 60 C Room temperature water approx 70 F or 21 C Neodisher MediZym diluted at 2 0 Warm water...

Page 27: ...ure 4 F to 140 F 20 C to 60 C Reprocessing the water tub and air outlet Disassembling The following instructions provide guidance on how to correctly disassemble the cleanable water tub and the air outlet 1 Remove the water tub from the device open it and discard any remaining water 2 Hold the water tub base and then fully open the water tub lid and pull it away so that it easily detaches from the...

Page 28: ...ons Detergent Water temperature Cleanable water tub Air outlet Alconox diluted at 1 Hot water approx 140 F or 60 C Warm water approx 113 to 140 F or 45 to 60 C Room temperature water approx 70 F or 21 C Neodisher MediZym diluted at 2 0 Warm water approx 113 to 140 F or 45 to 60 C High level thermal disinfection Part Validated number of cycles Hot water 194 F 90 C for 1 minute Cleanable water tub 1...

Page 29: ...tlet with the seal pointing to the left and the clip pointing forward 2 Make sure that the air outlet is correctly aligned and insert the air outlet into the socket It will click in place 3 Check if the air outlet is inserted correctly as shown To insert the water tub seal 1 Place the seal into the lid 2 Press down along all edges of the seal until it is firmly in place ...

Page 30: ...rt one side of the lid into the pivot hole of the base 2 Slide the other side down the ridge until it clicks into place Packaging and storage Store in a dry dust free environment away from direct sunlight Storage temperature 4 F to 140 F 20 C to 60 C ...

Page 31: ...ignal strength icon displayed at the top right of the screen indicates the signal strength Advise the patient to check the signal strength on their device Notes Therapy data might not be transmitted if used outside of the country or region of purchase Devices with cellular communication might not be available in all regions SD card Every AirSense 10 device comes with an SD card already inserted an...

Page 32: ... SD Card to AirView card to cloud Summary data compliance data 365 Detailed data Limited by usage and SD card storage capacity High resolution flow and pressure data 25 Hz Detailed data are stored on the SD card and can be viewed on ResScan Examples of detailed data available are shown below Detailed Data Parameter Sampling rate Apnea or hypopnea events Aperiodic CSR Aperiodic RERA AirSense 10 Aut...

Page 33: ...vice set up at home The icon will indicate the strength of coverage by the number of bars displayed the higher the number of bars the stronger the signal Traveling Patients can take their AirSense 10 device wherever they go Advise patients of the following Use the travel bag provided to prevent damage to the device Empty the water tub and pack it separately in the travel bag Make sure the patient ...

Page 34: ...ClimateLineAir user guide The patient is getting a very dry mouth Air may be escaping through the patient s mouth Increase the Humidity Level The patient may need a chin strap to keep the mouth closed or a full face mask The patient feels that too much air is being delivered from the device Ramp may be turned off Use the Ramp Time option The patient feels that not enough air is being delivered fro...

Page 35: ...hat therapy data can be sent using the SD Card Device may be in Airplane Mode Turn off Airplane Mode for instructions see the User Guide SmartStart is enabled but the device does not automatically start when the patient breathes into their mask Breath is not deep enough to trigger SmartStart To start therapy take a deep breath in and out through the mask before breathing normally Press Start There...

Page 36: ... Move the switch on the SD Card from the lock position to the unlock position and then re insert it Date and time can not be set in the past Date and time were not set before data was recorded Select Erase Data in Settings Once the data is erased set the correct local date and time System fault refer to user guide Error 004 Device may have been left in a hot environment Allow to cool before re use...

Page 37: ... normal operation in the configuration in which it will be used The use of accessories other than those specified for the device is not recommended They may result in increased emissions or decreased immunity of the device CAUTION Use only ResMed parts and accessories with the device Non ResMed parts may reduce the effectiveness of the treatment and or damage the device Use only vented masks recom...

Page 38: ...all applicable electromagnetic compatibility requirements EMC according to IEC60601 1 2 2007 for residential commercial and light industry environments It is recommended that mobile communication devices are kept at least 1 m away from the device Information regarding the electromagnetic emissions and immunity of this ResMed device can be found on www resmed com on the Products page under Service ...

Page 39: ...opylene fibers in a polypropylene carrier Efficiency 98 for 7 8 micron dust 80 for 0 5 micron dust Aircraft use ResMed confirms that device meets the Federal Aviation Administration FAA requirements RTCA DO 160 section 21 category M for all phases of air travel Wireless module Technology used CDMA USA and Canada only 2G GSM all regions except USA and Canada FCC ID 2ACHL AIR10CD The AirSense 10 dev...

Page 40: ...ld not be fitted to the mask Do not use electrically conductive or antistatic air tubing The temperature and relative humidity settings displayed are not measured values Displayed values Value Range Display resolution Pressure sensor at air outlet Mask pressure 4 20 cm H2O 0 1 cm H2O Flow derived values Leak 0 120 L min 1 L min Value Accuracy Pressure measurement1 Mask pressure2 0 5 cm H2O 4 of me...

Page 41: ...nse 10 and SlimLine AirSense 10 humidification and ClimateLineAir cm H2O L min L min L min L min 4 180 143 162 149 8 168 135 151 129 12 157 136 140 137 16 144 134 128 125 20 131 123 117 115 Symbols The following symbols may appear on the product or packaging Read instructions before use Indicates a warning or caution Follow instructions before use Manufacturer European Authorized Representative Ba...

Page 42: ...nts that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below Product Warranty period Mask systems including mask frame cushion headgear and tubing excluding single use devices Accessories excluding single use devices Flex type finger pulse sensors Humidifier water tubs 90 days Batteries for use in ResMed internal and e...

Page 43: ...ve limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you This warranty gives you specific legal rights and you may al...

Page 44: ...ense AirView AutoSet ClimateLine EPR HumidAir ResScan SlimLine and SmartStart are trademarks of ResMed Ltd AutoSet ClimateLine EPR SlimLine and SmartStart are registered in U S Patent and Trademark Office Actichlor is a trademark of Ecolab US Inc Alconox is a trademark of Alconox Inc Cavicide is a registered trademark of Metrex Research LLC Mikrozid and Terralin are trademarks of Schülke Mayr GmbH...

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