User Manual

ManualsBrandsResMed ManualsElectronicsContinuous Positive Airway Pressure Device

Table Of Contents

ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and

not to be used in any unauthorised way.



ResMed Ltd 2016.

DOC NO 378015

PAGE 1 of 35

SPECIFICATION

– PRINTED MATERIALS

REV 5

Rev Change

Note

Date

document

drafted

Document prepared by

(Name)

Document Checked by

(Name)

1 C36080 11 Mar 2014 Lisa Oliver Alison Besley (or delegate - refer to change note)

2 C36759 28 May 2014 Lisa Oliver

Catherine Macalpine

Alison Besley (or delegate – refer to change note)

3 C37528 18 Aug 2014 Verena Pirnbacher Alison Besley (or delegate – refer to change note)

4 mC0362 15 Jan 2016 Priya Varghese Alison Besley (or delegate – refer to change note)

5 mC0484 1 Aug 2016 Melanie Theaker Kristina Poeche or delegate refer to change note

AirCurve 10 VAuto S ST User Guide (device with humidifier)

AMER Eng Ref

Reference for internal use only

Not for printing or web publishing

1. DOCUMENT SCOPE

This guide has been developed in Author-it.

The content is written in AMER Eng in order to make sure that only one language (AmE) is used consistently for

all Newport content in the production database. Imperial measurements, metric measurements as well as

cm H

O and hPa are included where applicable.

Once published from Author-it the following changes are applied to create this AMER Eng Ref:

• Instances of hPa deleted with exception of:

Environmental conditions, Operating altitude: “Sea level to 8,500’ (2,591 m); air pressure range

1013 hPa to 738 hPa”.

This guide includes content which is applicable to:

Device: AirCurve 10 VAuto S ST

Integrated humidifier (standard water tub): Yes

Integrated humidifier (cleanable water tub): No

CAM: Yes

Images and screens show an AirCurve 10 S device.

2. CHANGE HISTORY

This change history provides an overall summary to assess importance of changes when documents are later

introduced onto a BOM. Document versions, copyright and release dates are automatic updates and not detailed

below.

Summary of content (35 pages)

PAGE 1
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016.
PAGE 2
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016.
PAGE 3
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016. SPECIFICATION – PRINTED MATERIALS DOC NO 378015 PAGE 3 of 35 REV 5 At a glance Addition of ‘ClimateLineAir Oxy’ to the Air Tubing (heated and non-heated) bullet, under the range of accessories available for use with the device.
PAGE 4
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016. SPECIFICATION – PRINTED MATERIALS DOC NO 378015 PAGE 4 of 35 REV 5 Object ID 18953: 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.
PAGE 5
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016. SPECIFICATION – PRINTED MATERIALS Technical specifications Symbols DOC NO 378015 PAGE 5 of 35 REV 5 • Not included as not available on D000-0245 for this version.
PAGE 6
ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2016.
PAGE 7
User guide
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User guide User guide English 378015r5_Covers.
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378015r5_Covers.
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ENGLISH Welcome The AirCurve 10 VAuto, AirCurve 10 S and AirCurve 10 ST are bilevel positive airway pressure devices. WARNING Read this entire guide before using the device. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. Indications for use AirCurve 10 VAuto The AirCurve 10 VAuto device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital use.
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Adverse effects You should report unusual chest pain, severe headache, or increased breathlessness to your prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment. The following side effects may arise during the course of therapy with the device: • drying of the nose, mouth, or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes.
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About your device 1 Air outlet 5 Water tub 2 Air filter cover 6 Screen 3 Power inlet 7 Adapter cover 4 Serial number and device number 8 SD card cover About the control panel Start/Stop button Press to start/stop therapy. Press and hold for three seconds to 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.
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Setup CAUTION Do not overfill the water tub as water may enter the device and air tubing. 1. Place the device on a stable level surface. 2. Plug the power connector into the rear of the device. Connect one end of the power 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 distilled water up to the maximum water level mark.
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Starting therapy 1. Fit your mask. 2. Press Start/Stop or breathe normally if SmartStart™ is enabled. You will know that therapy is on when the Sleep Report screen is displayed. The pressure bar shows the inspiratory and expiratory pressures in green. The green bar will expand and contract as you breathe in 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.
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Power save mode Your AirCurve 10 device records your therapy data. In order to allow it to transmit the data to your care provider, you should not unplug the device. However, you can put it into power save mode to save electricity. To enter power save mode: • Press and hold Start/Stop for three seconds. The screen goes black. To exit power save mode: • Press Start/Stop once. The Home screen is displayed.
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Humidity Level The humidifier moistens the air and is designed to make therapy more comfortable. If you are getting a dry nose or mouth, turn up the humidity. If you are getting any moisture in your mask, turn down the humidity. You can set the Humidity Level to Off or between 1 and 8, where 1 is the lowest humidity setting and 8 is the highest humidity setting. To adjust the Humidity Level: 1. In My Options, turn the dial to highlight Humidity Level and then press the dial. 2.
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Caring for your device It is important that you regularly clean your AirCurve 10 device to make sure you receive optimal therapy. The following sections will help you with disassembling, cleaning, checking and reassembling your device. WARNING Regularly clean your tubing assembly, water tub and mask to receive optimal therapy and to prevent the growth of germs that can adversely affect your health. Disassembling 1.
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Checking You should regularly check the water tub, air tubing and the air filter for any damage. 1. Check the water tub: • Replace it if it is leaking or has become cracked, cloudy or pitted. • Replace it if the seal is cracked or torn. • Remove any white powder deposits using a solution of one part household vinegar to 10 parts water. 2. Check the air tubing and replace it if there are any holes, tears or cracks. 3. Check the air filter and replace it at least every six months.
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Wireless Your AirCurve 10 device is equipped with cellular communication. This allows your therapy data to be wirelessly transmitted to your care provider to enhance the quality of your treatment. It also allows therapy settings to be updated in a more timely manner or your device software to be upgraded. The Wireless signal strength icon displayed at the top right of your screen indicates the signal strength. The data is usually transmitted after therapy has stopped.
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Traveling You can take your AirCurve 10 device with you wherever you go. Just keep the following in mind: • 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 you have the appropriate power cord for the region you are traveling to. For information on purchasing, contact your care provider. • If you are using an external battery, you should turn off the humidifier in order to maximize the life of your battery.
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Troubleshooting If you have any problems, have a look at the following troubleshooting topics. If you are not able to fix the problem, contact your care provider or ResMed. Do not try to open the device. General troubleshooting Problem/possible cause Solution 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 to check your mask fit and seal.
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Problem/possible cause Solution My water tub is leaking Water tub may not be assembled correctly. Check for damage and reassemble the water tub correctly. Water tub may be damaged or cracked. Contact your care provider for a replacement. My therapy data has not been sent to my care provider Wireless coverage may be poor. Make sure that the device is placed where there is coverage (ie, on your bedside table, not in a drawer or on the floor).
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Device message/possible cause Solution SD card error, remove your card and press Start to begin therapy SD card may not be inserted correctly. Remove and reinsert the SD card. Read only card, please remove, unlock and re-insert SD card SD card switch may be in the lock (read-only) position. Move the switch on the SD Card from the lock position the unlock position and then re-insert it. to System fault, refer to user guide, Error 004 Device may have been left in a hot environment.
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Reassembling parts Some parts of your device are designed to easily come off in order to avoid damage to the parts or the device. You can easily reassemble them as described below. 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. To reassemble the water tub lid: 1. Insert 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.
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General warnings and cautions WARNING • Make sure that you arrange the air tubing so that it will not twist around the head or neck. • Make sure the power cord and plug are in good condition and the equipment is not damaged. • Keep the power cord away from hot surfaces.
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• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the device, the water tub or air tubing. These solutions may cause damage or affect the humidifier performance and reduce the life of the products. • If you use the humidifier, always place the device on a level surface lower than your head to prevent the mask and air tubing from filling with water.
PAGE 27
Sound Pressure level measured according to ISO 80601-2-70:2015 (CPAP mode): SlimLine: 25 dBA with uncertainty of 2 dBA Standard: 25 dBA with uncertainty of 2 dBA SlimLine or Standard and humidification: 27 dBA with uncertainty of 2 dBA Power level measured according to ISO 80601-2-70:2015 (CPAP mode): SlimLine: 33 dBA with uncertainty of 2 dBA Standard: 33 dBA with uncertainty of 2 dBA SlimLine or Standard and humidification: 35 dBA with uncertainty of 2 dBA Declared dual-number noise emission values in acc
PAGE 28
Operating pressure range S, ST, T: VAuto: CPAP: Supplemental oxygen Maximum flow: 3 to 25 cm H2O (3 to 25 hPa) 4 to 25 cm H2O (4 to 25 hPa) 4 to 20 cm H2O (4 to 20 hPa) For VAuto device: 4 L/min (CPAP, S, VAuto) For S device: 4L/min (CPAP, S) For ST device: 15 L/min (CPAP, S, ST, T) Pneumatic flow path 1. Flow sensor 2. Blower 3. Pressure sensor 4. Mask 5. Air tubing 6. Water tub 7. Device 8.
PAGE 29
Air tubing Air tubing Material ClimateLineAir Flexible plastic and electrical components ClimateLineAir Oxy Flexible plastic and electrical components SlimLine Flexible plastic Standard Flexible plastic Heated air tubing temperature cut-out: ≤ 106°F (≤ 41°C) Length 6'6" (2 m) 6'4" (1.9 m) 6' (1.8 m) 6'6" (2 m) Inner diameter 0.6" (15 mm) 0.75" (19 mm) 0.6" (15 mm) 0.75" (19 mm) Notes: • The manufacturer reserves the right to change these specifications without notice.
PAGE 30
Pressure accuracy Maximum static pressure variation at 10 cm H2O (10 hPa) according to ISO 80601-2-70:2015 Standard air tubing SlimLine air tubing Without humidification ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.5 hPa) With humidification ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.
PAGE 31
Device without humidification and SlimLine air tubing / Device with humidification and SlimLine air tubing Breath Inspiratory pressure (cm H2O [hPa]) (Means, Standard Deviations) rate 6 10 16 21 25 10 BPM -0.26, 0.01 / -0.52, -0.25, 0.02 / -0.53, -0.24, 0.02 / -0.53, -0.25, 0.02 / -0.54, -0.20, 0.02 / -0.51, 0.01 0.02 0.01 0.02 0.02 15 BPM -0.26, 0.01 / -0.51, -0.25, 0.01 / -0.54, -0.26, 0.01 / -0.56, -0.31, 0.03 / -0.58, -0.30, 0.05 / -0.60, 0.01 0.01 0.01 0.02 0.03 20 BPM -0.25, 0.02 / -0.52, -0.29, 0.
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Symbols The following symbols may appear on the product or packaging. Read instructions before use. use. Manufacturer. Catalog number. Indicates a warning or caution. Follow instructions before European Authorized Representative. Serial number. Device number. Batch code. On / Off. Device weight. Protected against finger sized objects and against dripping water when tilted up to 15 degrees from specified orientation. Humidity limitation. control logo 1. Direct current. Type BF applied part.
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Product Warranty period • CPAP and bilevel device data modules • Oximeters and CPAP and bilevel device oximeter adapters • Humidifier cleanable water tubs • Titration control devices • CPAP, bilevel and ventilation devices (including external power supply units) 2 years • Humidifiers • Battery accessories • Portable diagnostic/screening devices This warranty is only available to the initial consumer. It is not transferable.
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378015r5_Covers.
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ResMed Ltd DISTRIBUTED BY 1 Elizabeth Macarthur Drive ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA Bella Vista NSW 2153 Australia ResMed (UK) Ltd 96 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK See www.resmed.com for other ResMed locations worldwide. For patent information, see www.resmed.com/ip. AirCurve, Air10, ClimateLine, HumidAir and SlimLine are trademarks and/or registered trademarks of the ResMed family of companies. SD Logo is a trademark of SD-3C, LLC.