ResMed S9 Series Clinical Manual
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ResMed S9 Series Clinical Manual

Positive airway pressure devices; heated humidifier
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368220/5 2011-09
S9 Series
H5i
CLINICAL
AMER ENG
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001 Spectrum Center
Boulevard San Diego CA 92123 USA.
ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK. See www.resmed.com for other
ResMed locations worldwide.
S9: Protected by one or more patents: AU 691200, AU 697652, AU 702820, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761,
AU 764761, AU 779327, AU 2007252223, CN 200780001837.6, EP 0651971, EP 0661071, EP 0920845, EP 0927538, EP 0934723, EP 1028769, EP 1126893,
EP 1144036, EP 1502618, EP 2032857, JP 3580776, JP 3778797, JP 4647786, NZ 504595, NZ 570415, NZ 573921, NZ 577485, US 5704345, US 6138675,
US 6240921, US 6363933, US 6367474, US 6425395, US 6502572, US 6591834, US 6675797, US 6745768, US 6817361, US 6988498, US 7040317,
US 7100608, US 7537010, US 7866944. Other patents pending. Protected by design registrations: AU 329025, AU 330142, AU 331272, AU 332891,
AU 333858, CN 200830346524.1, CN 200830346526.0, CN 200830346525.6, CN 201030215797.X, EU 1067417, JP 1377401, JP 1377402, JP 1377403,
JP 1415251, JP 1415252, NZ 411762, NZ 413090, NZ 413091, US D629891, US D629892, US D635232, US D635244, US D635245, US D635654, US D638536,
US D638537, US D638933. Others pending. H5i: Protected by patents: AU 2002233025, CN ZL02804936.5, HK 1065483, JP 4420605, NZ 527088, US 6935337,
US 7614398. Other patents pending. Protected by design registrations: AU 331676, AU 331677, CN 200930203243.5, EU 1720582, JP 1402844, JP 1402845,
NZ 413752, NZ 413753, US D626642, US D627044. Other designs pending.
S9, AutoSet, S9 Elite, S9 Escape Auto, S9 Escape, H5i, SlimLine, ClimateLine and SmartStart are trademarks of ResMed Ltd. S9, AutoSet, Escape, SlimLine,
ClimateLine and SmartStart are registered in U.S. Patient and Trademark Office.
© 2011 ResMed Ltd.
Global leaders in sleep and respiratory medicine
www.resmed.com
AutoSet
™
AutoSet
for Her
™
Elite
™
Escape Auto
™
Escape
™
POSITIVE AIRWAY PRESSURE DEVICES
H5i
™
H5i
for Her
™
HEATED HUMIDIFIER
Clinical Guide
English

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Summary of Contents for ResMed S9 Series

  • Page 1 NZ 413752, NZ 413753, US D626642, US D627044. Other designs pending. S9, AutoSet, S9 Elite, S9 Escape Auto, S9 Escape, H5i, SlimLine, ClimateLine and SmartStart are trademarks of ResMed Ltd. S9, AutoSet, Escape, SlimLine, ClimateLine and SmartStart are registered in U.S. Patient and Trademark Office.

  • Page 3: Table Of Contents

    Contents Welcome ..................... 1 S9 AutoSet indications for use ............. 1 S9 AutoSet for Her indications for use ..........1 S9 Elite indications for use ..............1 S9 Escape Auto indications for use ............1 S9 Escape indications for use .............. 1 S9 contraindications ................
  • Page 4 Data management ..................24 SD card ...................... 24 Removing the card ................24 Inserting the card ................24 Analyzing the SD card data ..............25 Data storage ..................25 Data transmission adapters ..............25 Cleaning and maintenance ................. 26 Daily ....................26 Weekly ....................

  • Page 5: Welcome

    Welcome Thank you for choosing the S9 Series or H5i. Before operating these devices, please read the entire Clinical and Information Guides. S9 AutoSet indications for use The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).

  • Page 6: H5I Indications For Use

    H5i indications for use The H5i is indicated for the humidification of the air delivered from a CPAP or bilevel device. The H5i is for use only as recommended by a physician. The H5i is intended for single patient re-use in the home environment and re-use in a hospital/institutional environment.

  • Page 7: S9 At A Glance

    Advise the patient to purchase and travel with the approved power cord for the region where they will be using the S9 device. • ResMed confirms that the S9 Series meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160F , section 21, category M) for all phases of air travel. English...

  • Page 8: H5I At A Glance

    Flip lid seal Flip lid Air outlet Release button ClimateLine / ClimateLine connection port Latch water tub H5i at a glance The H5i system comprises the following elements: • H5i heated humidifier • H5i water tub • ClimateLine heated air tubing (if sold as a Climate Control Kit). Optional components include: •...

  • Page 9: Operating Information

    Operating information The following table describes the operating modes available on the S9 Series. Mode S9 Escape AutoSet Elite Auto Escape CPAP mode A fixed pressure is delivered with optional Expiratory Pressure Relief (EPR). EPR can ü ü ü ü...

  • Page 10: Autoset Technology

    AutoSet technology The treatment pressure required by your patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The device analyzes the state of your patient’s upper airway on a breath-by-breath basis and delivers pressure within the allowed range according to the degree of obstruction.

  • Page 11: Apneas

    Apneas The APAP algorithm only treats apneas up to 10 cm H O and does not differentiate between different types of apneas. The enhanced AutoSet algorithm detects both obstructive and central apneas. If an apnea occurs, the device responds appropriately. Obstructive apnea An obstructive apnea is when the upper airway becomes severely limited or completely obstructed.

  • Page 12: New To The S9 Platform

    New to the S9 platform Climate Control S9 devices, when used in conjunction with the H5i and ClimateLine or ClimateLine heated air tubing, offer a feature called Climate Control. Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient’s upper airway while protecting against rainout and allowing patients to select the air temperature that offers the most comfort for them.

  • Page 13: Central Sleep Apnea

    Central sleep apnea The S9 AutoSet and S9 Elite detect both obstructive and central sleep apneas (CSA). CSA detection uses the Forced Oscillation Technique (FOT) to determine the state of the patient’s airway during an apnea. When an apnea has been detected, small oscillations in pressure (1 cm H O peak-to-peak at 4 Hz) are added to the current device pressure.

  • Page 14: Data Management

    Data management Designed to make data more easily available, the S9 SD card gives clinicians greater insight to patient therapy by making high resolution flow and detailed data available on the S9 AutoSet and S9 Elite. The amount of data stored on the SD card varies compared to the data stored on the device. Note: The S9 Escape and S9 Escape Auto only provide compliance and therapy summary and statistic data.

  • Page 15: Setup

    “Nasal Ultra” setting. • For a complete list of recommended masks and their settings go to www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.

  • Page 16: Filling The Water Tub

    Filling the water tub 1. Slide the latch and lift open the flip lid. 2. Remove the water tub. 3. Fill the water tub (through the center hole) with distilled or deionized water up to the maximum water level mark (12.5 fl oz / 380 mL). 4.

  • Page 17: S9 Basics

    S9 basics LCD screen Home menu Start/Stop button Starts or stops treatment. Setup menu Allows you to make changes to settings. Info menu Allows you to view your sleep Push Dial statistics. Turning the dial allows you to scroll through the menu and change settings.

  • Page 18: Navigating The Menus

    Navigating the menus In general, to navigate the menus: 1. Turn until the 2. Press 3. Turn until you 4. Press to confirm parameter you The selection is see the setting that your choice. The require is displayed highlighted in you require.

  • Page 19: Changing Settings Via The Home Menu

    Changing settings via the Home menu From the home menu, you can adjust or check the following features: Ramp Designed to make the beginning of treatment more comfortable for the patient, ramp time is the period during which the pressure increases from an initial pressure to the prescribed treatment pressure or minimum treatment pressure.

  • Page 20: Treatment Screens

    Treatment screens Depending on how the system has been configured, you will see one of the following screens when the device is running: ü H5i humidifier ü H5i humidifier ü H5i humidifier ü ClimateLine or ü ClimateLine or ClimateLine heated air ClimateLine heated air tube...

  • Page 21: Setup Menu

    Advanced Info menu (Hold for 3 sec) To access the Advanced Info menu, press and hold the Info and Setup buttons for three seconds. This provides patients with additional therapy settings and compliance information. This screen provides the same options as shown on the Clinical Info menu on the following page. Setup menu The Setup menu consists of: •...

  • Page 22: Reminder Menu

    Clinical Info menu (accessed from the Clinical Setup menu) *Mask Fit and Leak are only available in the S9 AutoSet and S9 Elite. AHI is not available in the S9 Escape. Reminder menu You can use the Reminder menu to alert a patient to specific events, such as when to replace their mask (shown below) or when to insert an SD card.

  • Page 23: Managing Climate Control

    Managing Climate Control Designed to be ideal for most patients, Climate Control Auto enables the automatic delivery of a constant value of absolute humidity while protecting against rainout. To allow for increased flexibility, Climate Control can be turned to Manual in either the Patient Setup (when enabled) or the Clinical Setup menus.

  • Page 24: Treatment Screen And Clinical Setup Menus

    Treatment screen and clinical setup menus Parameter Modes Default Range Description AutoSet APAP CPAP Treatment screen AutoSet Shows the treatment ü pressure. 4 cm H 20 cm H APAP Shows the treatment ü pressure. 4 cm H 20 cm H CPAP Shows the set pressure.
  • Page 25 Parameter Modes Default Range Description AutoSet APAP CPAP Options Climate Auto Auto / Manual / Sets the type of Climate ü ü ü Control Patient Control. Sleep quality Usage On / Usage Sets Sleep Quality to Usage ü ü ü or On.
  • Page 26 Parameter Modes Default Range Description AutoSet APAP CPAP Service – – Displays the current software ü ü ü version. Reminders Mask Seven-day A timed reminder to remind ü ü ü increments a patient when they need to (starting from the replace their mask.

  • Page 27: Delivering Therapy

    Delivering therapy 1. Make sure the power is connected. 2. Adjust the ramp time or humidification level if required. 3. Instruct the patient to fit their mask as described in the mask user guide. 4. To start therapy, instruct the patient to breathe into the mask and/or press 5.

  • Page 28: Data Management

    365 sessions. SD card The SD card allows S9 devices to capture data. The S9 Series comes with the SD card already inserted and ready to be used. Compliance data is also stored on the device, so if the card is lost, the data is not.

  • Page 29: Analyzing The Sd Card Data

    Analyzing the SD card data To analyze the data, use a ResMed PC application to transfer data and settings between an S9 or an SD card and your personal computer. Refer to your PC application guide for more information about analyzing the information on returned SD cards.

  • Page 30: Cleaning And Maintenance

    Cleaning and maintenance You should regularly carry out cleaning and maintenance as described in this section. Daily 1. Remove the air tubing by pulling on the finger grips on the cuff. Hang it in a clean, dry place until next use.

  • Page 31: Maintenance Checklist

    1. Remove the air filter cover from the back of the S9 device. 2. Remove and discard the old filter. 3. Insert a new ResMed air filter ensuring that it is sitting flat in the air filter cover. 4. Replace the air filter cover.

  • Page 32: Technical Specifications

    (EMC) according to IEC60601-1-2:2007 , for residential, commercial, and light industry environments. Information regarding the electromagnetic emissions and immunity of these ResMed devices can be found on www.resmed.com, on the Products page under Service and Support. Click on the PDF file for your language.
  • Page 33 S9 technical specifications Operating pressure range 4 to 20 cm H Maximum single fault steady 30 cm H O if pressure exceeded for >6 sec state pressure 40 cm H O if pressure exceeded for >1 sec Pressure measurement ±0.5 cm H O ±...
  • Page 34 RH output % Nominal system output AH , BTPS pressure cm H Setting 3 Setting 6 Setting 3 Setting 6 11.5 AH- Absolute Humidity in mg/L. BTPS- Body Temperature Pressure Saturated. Pneumatic flow path S9 Series Mask Inlet filter Blower Tube...
  • Page 35 Flow (maximum) at set pressures The following are measured at the end of the specified tubing: Pressure S9 and S9 and S9, H5i and cm H Standard air tube SlimLine air tube ClimateLine heated air tube L/min L/min L/min Displayed values Value Range Accuracy...

  • Page 36: Warnings And Cautions

    Do not use your S9 if there are obvious external defects or unexplained changes in performance. • Only ResMed air tubing and accessories should be used with these devices. A different type of air tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of your treatment.

  • Page 37: S9 Cautions

    (32ºC). H5i WARNINGS • The H5i is designed only for use with S9 Series devices. Do not use the H5i with any other CPAP device. • Do not operate the H5i if it is not working properly or if any part of the CPAP device or H5i has been dropped or damaged.

This manual is also suitable for:

H5i seriesS9 autosetS9 autoset for herS9 eliteS9 escape autoS9 escape ... Show all

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