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ResMed AirCurve 10 ST-A, Clinical Manual, Page: 2 / 60

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Contents 

Welcome ................................................................................................................................... 1

 

Indications for use ................................................................................................................ 1

 

AirCurve 10 ST-A ........................................................................................................... 1

 

Contraindications.................................................................................................................. 1

 

Adverse effects .................................................................................................................... 1

 

At a glance ................................................................................................................................ 2

 

About your device ................................................................................................................ 3

 

About the control panel ........................................................................................................... 4

 

Therapy information................................................................................................................. 5

 

CPAP mode.......................................................................................................................... 5

 

Bilevel modes ...................................................................................................................... 5

 

S (Spontaneous) mode ................................................................................................... 5

 

ST (Spontaneous/Timed) mode ...................................................................................... 5

 

T (Timed) mode .............................................................................................................. 5

 

PAC (Pressure Assist Control) mode .............................................................................. 5

 

iVAPS (intelligent Volume Assured Pressure Support) mode .......................................... 5

 

More about iVAPS ................................................................................................................ 8

 

Target alveolar ventilation .............................................................................................. 9

 

intelligent Backup Rate (iBR) ................................................................................................ 9

 

Triggering and cycling ........................................................................................................ 10

 

TiControl - Inspiratory time control ..................................................................................... 11

 

Rise time adjustment ......................................................................................................... 12

 

Leak management with VSync ........................................................................................... 12

 

Comfort features ..................................................................................................................... 12

 

Ramp ................................................................................................................................. 12

 

Ramp Down ....................................................................................................................... 13

 

Climate Control .................................................................................................................. 13

 

Climate Control Auto .................................................................................................... 13

 

Climate Control Manual ................................................................................................ 14

 

Setup ....................................................................................................................................... 15

 

Supplemental oxygen ......................................................................................................... 16

 

Antibacterial filters ............................................................................................................. 16

 

Accessing and exiting the Clinical Menu............................................................................... 16

 

Adjusting the clinical settings ............................................................................................. 17

 

Setting the date and time ............................................................................................. 18

 

QuickNav ........................................................................................................................... 18

 

Settings menu .................................................................................................................... 18

 

Therapy ........................................................................................................................ 18

 

Comfort ....................................................................................................................... 20

 

Accessories ................................................................................................................. 21

 

Alarms ......................................................................................................................... 21

 

Options ........................................................................................................................ 22

 

Configuration ............................................................................................................... 22

 

Configuring iVAPS .............................................................................................................. 23

 

Using Learn Targets ..................................................................................................... 23

 

Entering the target values manually ............................................................................. 24

 

Working with alarms .............................................................................................................. 24

 

Muting activated alarms ..................................................................................................... 24

 

Viewing the alarms ............................................................................................................. 25

 

Summary of Contents for AirCurve 10 ST-A

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

Page 2: ...ggering and cycling 10 TiControl Inspiratory time control 11 Rise time adjustment 12 Leak management with VSync 12 Comfort features 12 Ramp 12 Ramp Down 13 Climate Control 13 Climate Control Auto 13 C...

Page 3: ...36 Inspecting 37 Reassembling 37 Packaging and storage 38 Data management and therapy compliance 38 Remote monitoring 38 SD card 38 Data storage 39 Software upgrade 40 Managing patient care 40 Patient...

Page 4: ...environment and re use in a hospital institutional environment Contraindications Positive airway pressure therapy may be contraindicated in some patients with the following pre existing conditions sev...

Page 5: ...ncluding Air tubing heated and non heated ClimateLineAir ClimateLineAir Oxy SlimLine Standard Water tub Standard water tub cleanable water tub can be disinfected Filter Hypoallergenic filter standard...

Page 6: ...About your device 1 Air outlet 6 HumidAir humidifier water tub 2 Air filter cover 7 Screen 3 Retention clip 8 Adapter cover 4 Power inlet 9 SD card cover 5 Serial number and device number 10 LED alarm...

Page 7: ...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 includi...

Page 8: ...ngly The difference between IPAP and EPAP levels helps determine the tidal volume ST Spontaneous Timed mode In ST mode the device augments any breath initiated by the patient but will also supply addi...

Page 9: ...6 The following diagram illustrates these operating modes...

Page 10: ...es in the AirCurve 10 device are shown below Parameter Mode S ST T PAC iVAPS CPAP Set Pressure IPAP EPAP Min PS Max PS Resp Rate Backup Rate Target Pt Rate Target Va Ti Ti Max Ti Min Rise Time Trigger...

Page 11: ...s the comfort and synchrony of pressure support but with the assurance offered by a volume target iVAPS has the following advantages over traditional VAPS schemes iVAPS is a unique combination for a s...

Page 12: ...ackup Rate iBR ST and iVAPS modes only Instead of mandating a fixed backup rate the intelligent Backup Rate iBR will shift automatically between two limits During sustained apnoea the iBR will adopt a...

Page 13: ...sensing level according to patient conditions Under normal conditions the device triggers initiates IPAP and cycles terminates IPAP and changes to EPAP as it senses the change in patient flow Patient...

Page 14: ...Ti Min parameters play a significant role in maximizing synchronization by effectively intervening to limit or prolong the inspiratory time when required This ensures synchronization even in the prese...

Page 15: ...Sync algorithm the AirCurve 10 device monitors and compensates for leak by continuously and automatically adjusting the baseline flow This enables reliable delivery of therapy pressure while maintaini...

Page 16: ...e ClimateLineAir and the HumidAir humidifier are attached Climate Control Auto Climate Control Auto is the recommended and default setting Climate Control Auto is designed to make therapy as easy as p...

Page 17: ...e therapy more comfortable If the patient is getting a dry nose or mouth turn up the humidity If the patient is getting moisture in their mask turn down the humidity The Humidity Level can be set to O...

Page 18: ...r cord into the power supply unit and the other end 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 dist...

Page 19: ...ntibacterial filters Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure particularly at high flows ResMed recommends using an anti...

Page 20: ...al settings 1 Access the Clinical Menu highlight Settings and press the dial The Settings menu is displayed 2 Turn the dial to highlight the setting you want to adjust and then press the dial 3 Turn t...

Page 21: ...screens and the Settings menu Changes can be made to the patient s settings whilst the patient is receiving treatment To use QuickNav From the Clinical Menu press the Home button twice to switch back...

Page 22: ...e rate input for iBR This should be set at the patient s actual respiratory rate 8 50 BPM ST mode 8 30 BPM iVAPS mode Target Va Determines the amount of pressure support required by the iVAPS algorith...

Page 23: ...Face Nasal Pillows Pediatric Comfort Parameter Description Mode Range S ST T PAC iVAPS CPAP Ramp Time Set the ramp time Off 5 45 mins Ramp Down Enable disable the Ramp Down feature Off On Start Pressu...

Page 24: ...mask may result in false triggering of the Non Vented Mask alarm On Off Low MV Sets the Low Minute Ventilation alarm Activates within 20 40 seconds after the measured level remains below the set limit...

Page 25: ...lace the humidifier Off 1 24 mths 1 month increments Tube Set a recurring reminder to the patient to replace the air tubing Off 1 24 mths 1 month increments Filter Set a recurring reminder to the pati...

Page 26: ...pplemental oxygen added is achieved follow the procedure below The device must be in standby to start the Learn Targets cycle During Learn Targets Tidal Volume and Respiratory Rate are recorded for ea...

Page 27: ...ing and mask are all firmly connected Adjustable alarms are set via the Settings menu When an alarm is activated the yellow LED alarm indicator will flash the alarm will sound and a message will appea...

Page 28: ...vice are classified as medium priority Fixed alarms Adjustable alarms The alarms pre set for the device are Power fail Blocked tube Tube disconnected System fault system error Alarms that can be set a...

Page 29: ...50 seconds To test the Tube disconnect alarm 1 Disconnect air tubing at the air outlet 2 Press Start Stop The alarm activates after 5 10 seconds To test the High leak alarm 1 Set the High leak alarm t...

Page 30: ...and out The screen will go black automatically after a short period of time You can press Home or the dial to turn it back on If power is interrupted during therapy the device will automatically resta...

Page 31: ...iding the total number of events that occurred by the total mask on therapy period in hours Mask Seal Good if the 70th percentile leak is less than 24 L min Mask needs adjustment Humidifier Humidifier...

Page 32: ...breathing expressed as the number of breaths per minute 5 breath moving average MV Average of the 50th percentile values of minute ventilation during the selected period for days with usage only Ti Du...

Page 33: ...ice 2 Open the water tub and discard any remaining water 3 Hold the cuff of the air tubing and gently pull it away from the device Grip the retention clip and pull up to release the power cord 4 Hold...

Page 34: ...ckages by dirt or dust To replace the air filter 1 Open the air filter cover and remove the old air filter The air filter is not washable or reusable 2 Place a new air filter onto the air filter cover...

Page 35: ...nd 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 D...

Page 36: ...onent according to the detergent manufacturer s instructions ResMed has tested the following detergents according to the manufacturer s instructions Detergent Water temperature SlimLine Standard Clima...

Page 37: ...re two additional times using fresh water for a total of three rinses 4 Air dry out of direct sunlight and or heat Inspecting Perform a visual inspection of the components If any visible deterioration...

Page 38: ...n fully open the water tub lid and pull it away so that it easily detaches from the base 3 Remove the water tub seal from the water tub lid by pulling it away 4 Align the swivel so that the connector...

Page 39: ...rmal disinfection Part Validated number of cycles Hot water 194 F 90 C for 1 minute OR 167 F 75 C for 30 minutes Cleanable water tub 10 Air outlet 10 1 Soak the disassembled components in a hot water...

Page 40: ...provide guidance on how to correctly reassemble the air outlet and the water tub To reassemble the air outlet 1 Hold the air outlet with the seal pointing to the left and the clip pointing forward 2 M...

Page 41: ...ote monitoring The AirCurve 10 device has cellular communication which has the ability to automatically transmit summary and detailed data on a regular basis It also allows you to change settings remo...

Page 42: ...are stored on the SD card and can be viewed with AirView and ResScan High resolution flow and pressure data are stored on the SD card Data can be transmitted to therapy management software either rem...

Page 43: ...patient menu there are two types of access levels Essentials and Essentials Plus Essentials is designed to make the device interaction and menu navigation easier for patients It is a simple choice fo...

Page 44: ...completely empty and inserted into the device The device will not work without the water tub inserted Turn on Airplane Mode for instructions see the User Guide CAUTION Do not use the device with wate...

Page 45: ...conjection with supplemental oxygen may result in falsue triggering of this alarm on a vented mask Increase EPAP No display Backlight on the screen may have turned off It turns off automatically afte...

Page 46: ...and out through the mask before breathing normally Press Start There is excessive leak Adjust the mask and headgear Air tubing may not be connected properly Connect firmly at both ends SmartStart is...

Page 47: ...y See mask user guide for fitting instructions or use the Mask Fit function to check mask fit and seal Displays messsage Tubing blocked check your tubing Air tubing may be blocked Check the air tubing...

Page 48: ...ResMed dealer or ResMed office Do not open the device All other error messages for example System fault refer to user guide Error 0XX An unrecoverable error has occurred on the device Contact your lo...

Page 49: ...and or damage the device Use only vented masks recommended by ResMed or by the prescribing doctor with this device Fitting the mask without the device blowing air can result in rebreathing of exhaled...

Page 50: ...obile communication devices are kept at least 1 m away from the device For further details see the Guidance and manufacturer s declaration electromagnetic emissions and immunity section EN 60601 1 200...

Page 51: ...ne 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...

Page 52: ...90 6 10 1 AH Absolute Humidity in mg L 2 BTPS Body Temperature Pressure Saturated Air tubing Air tubing Material Length Inner diameter ClimateLineAir Flexible plastic and electrical components 6 6 2...

Page 53: ...004 for Home Care Ventilatory Support Devices Figure 101 and Table 101 using nominal ResMed mask vent flows Measurement system uncertainties In accordance with ISO 80601 2 70 2015 the measurement unce...

Page 54: ...0 38 0 01 0 29 0 01 0 43 0 02 0 31 0 01 0 45 0 03 0 13 0 23 0 31 0 01 Device without humidification and SlimLine air tubing Device with humidification and SlimLine air tubing Breath rate Inspiratory p...

Page 55: ...st Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to...

Page 56: ...Hz to 2 5 GHz Recommended separation distance d 0 35 P d 0 35 P 80 MHz to 800 MHz d 0 70 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the...

Page 57: ...ting of the transmitter in watts W according to the transmitter manufacturer Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply i...

Page 58: ...e 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 sing...

Page 59: ...e 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 regi...

Page 60: ...tart ResScan AirView and VPAP are trademarks and or registered trademarks of the ResMed family of companies For patent and other intellectual property information see ResMed com ip Actichlor is a trad...

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