HumidAire 3i User Manual May 2006

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MANUEL UTILISATEUR

21

MANUAL DEL USUARIO

43

ESPAÑOL

MANUAL DO UTILIZADOR

65

FRANÇAIS

USER’S MANUAL

PORTUGUÊS

ENGLISH

HUMIDAIRE 3i™

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ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA ResMed (UK) Ltd (EU Authorized Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK ResMed Offices Australia, Austria, Brazil, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details). Patents and designs pending. HumidAire, HumidAire 3i, S8 and SmartStart are trademarks of ResMed Ltd and HumidAire is registered in U.S. Patent and Trademark Office. © 2006 ResMed Ltd.

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HumidAire 3i™ USER’S MANUAL English

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CONTENTS WELCOME... 3 WHAT IS THE HUMIDAIRE 3i?... 3 YOUR RESPONSIBILITY

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MEDICAL INFORMATION... 4 INTENDED USE CONTRAINDICATIONS WARNINGS

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COMPONENTS OF YOUR HUMIDAIRE 3i... 5 SETTING UP YOUR HUMIDAIRE 3i FOR USE... 6 REMOVING THE FRONT CAP (IF FITTED) REMOVING AND STORING THE CONNECTOR PLUG ATTACHING YOUR HUMIDAIRE 3i FILLING THE WATER CHAMBER

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STARTING AND STOPPING TREATMENT... 7 STARTING YOUR TREATMENT STOPPING YOUR TREATMENT DETACHING YOUR HUMIDAIRE 3i

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FREQUENTLY ASKED QUESTIONS... 9 CLEANING AND MAINTENANCE... 10 DISASSEMBLING YOUR HUMIDAIRE 3i CLEANING YOUR HUMIDAIRE 3i REASSEMBLING YOUR HUMIDAIRE 3i SERVICING

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TROUBLESHOOTING... 13 TECHNICAL SPECIFICATIONS... 15 LIMITED WARRANTY... 17 INDEX... 19

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Thank you for choosing the ResMed HUMIDAIRE 3i™ humidifier. The HUMIDAIRE 3i is designed to humidify (moisten) the air delivered to your airway during CPAP (continuous positive airway pressure) therapy. The HUMIDAIRE 3i attaches to your ResMed S8™ Series CPAP flow generator with a simple ‘click-in’ mechanism. This user manual contains the information you need for the correct use of your HUMIDAIRE 3i.

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WELCOME

WHAT IS THE HUMIDAIRE 3i? The HUMIDAIRE 3i is designed to form a single unit with a ResMed CPAP flow generator. The combined unit provides humidification during CPAP therapy, and can make therapy more comfortable. You may have experienced nasal congestion or dryness of the nose, mouth, or throat during CPAP therapy. These symptoms are caused by dry climates, cold air temperatures, the airflow delivered from your flow generator, or mouth leak. Moist air may help relieve these symptoms of dryness. Refer to your flow generator manual to see whether it is compatible with the HUMIDAIRE 3i. Contact your equipment supplier or ResMed office if you require further information.

YOUR RESPONSIBILITY You or the user of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from: • operation which is not in accordance with the operating instructions supplied • maintenance or modifications carried out unless in accordance with authorized instructions and by authorized persons. Please read this manual carefully before use. This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information. • Warning alerts you to possible injury. • Caution explains special measures for the safe and effective use of the device. • Note is an informative or helpful note.

WELCOME

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MEDICAL INFORMATION INTENDED USE The HUMIDAIRE 3i is indicated for humidification of the air delivered from the ResMed S8 Series CPAP devices. The HUMIDAIRE 3i is for use only as recommended by a physician.

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CAUTION (USA ONLY) Federal law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS The HUMIDAIRE 3i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed. Please also refer to the relevant system manual for contraindications associated with CPAP therapy.

WARNINGS The following are general warnings. Specific warnings and cautions appear next to the relevant instructions in the manual.

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WARNINGS • • • •

• •

•

•

•

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Use the HUMIDAIRE 3i only for its intended use as described in this manual. Make sure that the water chamber is empty before transporting the HUMIDAIRE 3i. The HUMIDAIRE 3i is designed only for use with specific ResMed CPAP devices. Do not use the HUMIDAIRE 3i with any other CPAP device. The HUMIDAIRE 3i should only be used with delivery tubes or accessories recommended by ResMed. Connection of other delivery tubes or accessories could result in injury, or damage to the device. The HUMIDAIRE 3i, including the associated tubing, is for single-patient use and must not be re-used on another person. This is to avoid the risk of cross-infection. Always place the HUMIDAIRE 3i device lower than the level of the patient. If it is placed at or above the level of the patient, heated water may flow down the air tubing and into the mask. There exists the possibility that if the device is placed above the level of the patient and is tipped over, or if the tubing is filled with condensate, the mask might fill with water. The HUMIDAIRE 3i should therefore be used with caution in patients who are unable to guard their airways, or are unable to pull the mask off, for example following a stroke. Attention should be given to the relative risks and benefits. Do not attempt to dismantle the HUMIDAIRE 3i docking station. There are no user-serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent. Take care when handling the HUMIDAIRE 3i. The heater plate and the water in the water chamber may be hot.

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• • • • • • •

If liquids are inadvertently spilled into or on the HUMIDAIRE 3i docking station, unplug the CPAP device from the power outlet. Disconnect the docking station from the CPAP device and allow the docking station to drain and dry before using. Do not operate the HUMIDAIRE 3i if the CPAP device has a damaged power cord or plug. Do not operate the HUMIDAIRE 3i if it is not working properly or if any part of it has been dropped or damaged. Keep the CPAP device power cord away from heated surfaces. Do not drop or insert any object into any opening or tubes. Do not use the HUMIDAIRE 3i in the presence of flammable or explosive materials. Explosion hazard-do not use in the vicinity of flammable anesthetics. If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. If oxygen has been left on, turn off the flow generator, then wait 30 minutes before turning on the flow generator again. Explanation: When the CPAP device is not in operation and the oxygen flow is left on, oxygen delivered into the air delivery tubing may accumulate within the CPAP machine enclosure and create a risk of fire. This applies to most types of CPAP machines. • Oxygen supports combustion. Oxygen should not be used while you are smoking or in the presence of an open flame. • Always ensure airflow is being generated by the device before the oxygen supply is turned on. • Always turn the oxygen supply off before stopping the airflow from the device.

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Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on where the oxygen is introduced, the pressure settings, patient breathing pattern, mask selection and leak rate.

COMPONENTS OF YOUR HUMIDAIRE 3i Please refer to the illustrations in section A of the illustration sheet.

COMPONENTS OF YOUR HUMIDAIRE 3i

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SETTING UP YOUR HUMIDAIRE 3i FOR USE !

WARNING Make sure your flow generator is switched off at the power outlet before connecting the HumidAire 3i.

REMOVING THE FRONT CAP (IF FITTED) Please refer to the illustrations in section B of the illustration sheet. Your flow generator may be fitted with a front cap (B-1). Before you can attach the HUMIDAIRE 3i, press the button underneath the front cap (B-2) and pull it away from the body of your flow generator (B-3 & B-4). Notes To replace the front cap, align it with your flow generator (B-4) and push it firmly until it clicks into place. • Remember to take the front cap with you when travelling, in case you need CPAP therapy without a humidifier. •

REMOVING AND STORING THE CONNECTOR PLUG Please refer to the illustrations in section C of the illustration sheet. Before attaching the HUMIDAIRE 3i, remove the connector plug from your flow generator (C-1) and attach it to the back of the docking station (C-2).

ATTACHING YOUR HUMIDAIRE 3i Please refer to the illustrations in section D of the illustration sheet.

1 Align your HUMIDAIRE 3i with your flow generator (D-1) and push them together until they click into place (D-2).

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WARNING The HumidAire 3i docking station should only be connected or disconnected when the water chamber is empty. • Water must be prevented from entering your flow generator. Do not transport the flow generator with the HumidAire 3i attached. •

2 Insert the power cord into the socket at the rear of your flow generator. Plug the other end of the power cord into a power outlet (D-3).

Note: If your flow generator is powered via the DC input, the HumidAire 3i is not powered and humidification output will be reduced.

3 Place the combined unit on a firm, level surface near your bed at a level lower than

your sleeping position. Ensure the surface is not sensitive to heat and/or moisture, or use a protective mat.

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CAUTION Be careful not to place the unit where it can be bumped into and knocked over.

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4 Connect one end of the air tubing firmly onto the air outlet of your HUMIDAIRE 3i FILLING THE WATER CHAMBER Please refer to the illustrations in section E of the illustration sheet.

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and the other end to your mask (D-4).

WARNING Take care when handling your HumidAire 3i. The water and the water chamber base may both be hot. Allow ten minutes for the heater plate and any excess water to cool.

1 Release the cover latch (E-1) and lift the cover until it rests in the upright position (E-2). 2 Remove the water chamber (E-3) and carefully fill it with fresh, clean water (E-4). Make sure you keep the level of the water under the maximum water level mark (E-4a). Always ensure that the water chamber is clean. See “Cleaning and Maintenance” on page 10.

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WARNING Do not overfill the water chamber, as water may enter your flow generator and air tubing.

CAUTION Do not use any additives (eg, scented oils and perfumes). They may reduce the humidification output of the HumidAire 3i and/or cause deterioration of the water chamber materials.

3 Carefully place the filled water chamber into the humidifier docking station (E-5) and latch the cover (E-6). The HUMIDAIRE 3i is now ready for use.

STARTING AND STOPPING TREATMENT STARTING YOUR TREATMENT Please refer to the illustration in section F of the illustration sheet.

1 When your HUMIDAIRE 3i is attached and the flow generator is powered, the

indicator light lights up on the HUMIDAIRE 3i. A prompt for the Warm-Up feature (not available on all models) may appear. RAMP: 10min menu  warmup

When activated, this feature allows the water to warm up before you start treatment.

2 If the Warm-Up feature is available, use it to pre-heat the water before starting your treatment. Skip this step if you wish to start treatment immediately.

STARTING AND STOPPING TREATMENT

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WARM-UP FEATURE (NOT AVAILABLE IN ALL MODELS) Note: Check your flow generator user’s manual to see if this feature is available. To start the Warm-Up feature: i. Select Warmup by pressing the Right key on the control panel. The following message is displayed for 2 seconds: HUMIDIFIER WARMING

ii. After 2 seconds the WARMING screen is displayed. WARMING menu

exit

iii. While your HUMIDAIRE 3i is in Warm-Up mode you can: • Start treatment at any time by pressing the Start/Stop key. • Access the menus by pressing Menu (Left key). • Stop the Warm-Up feature at any time by pressing Exit (Right key). The Warm-Up feature will automatically turn off after 30 minutes if treatment has not started.

3 Turn the humidity control dial to the desired setting. The

setting switches heated humidification off and delivers minimum humidification. The indicator light will remain lit to indicate standby mode. A setting of 6 ( ) delivers maximum humidification. We recommend that you initially set the control dial to 3 ( ). If necessary, adjust the control dial up or down to find the setting that is most comfortable and effective for you. You can adjust the humidity setting at any time. The aim is to have moist air delivered to your mask but to avoid condensation forming in the air tubing. The temperature and humidity of the surrounding air will affect the setting you need. See “Frequently Asked Questions” for further tips on the correct humidity setting.

4 Fit your mask as described in your mask user instructions. 5 Press the Start/Stop key on the control panel. Alternatively, if your flow generator has the SmartStart function available, simply breathe into your mask and air should begin to flow.

Note: During operation, the indicator light becomes brighter to indicate that the heating element is active. Your HumidAire 3i has a rapid heating element which allows very short heating times. Do not be concerned if the light only brightens very briefly.

6 Lie down and arrange the air tubing so that it is free to move if you turn in your sleep. WARNING

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Do not leave an excessive length of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping.

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To stop your treatment at any time, remove your mask and press the Start/Stop key. Alternatively, if your flow generator has the SmartStart function available, simply remove your mask and treatment will end. Some flow generators continue to blow air gently after you have stopped your treatment. This can continue for up to one hour to assist the heater plate in cooling. However, you can unplug the device from the power outlet at any time and allow the heater plate to cool without airflow.

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STOPPING YOUR TREATMENT

DETACHING YOUR HUMIDAIRE 3i Please refer to the illustrations in section G of the illustration sheet.

1 Unplug the power cord from the power outlet (G-1). WARNING

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Take care when handling your HumidAire 3i. The water and the water chamber base may both be hot. Allow ten minutes for the heater plate and any excess water to cool (G-2).

2 Remove the water chamber from the docking station (G-3). 3 Press the large silver button located midway underneath the docking station (G-4) and pull the HUMIDAIRE 3i and flow generator apart (G-5). Large silver button

UNDERSIDE VIEW

Note: Re-attach the connector plug firmly to your flow generator.

FREQUENTLY ASKED QUESTIONS WHY IS THERE CONDENSATION IN MY MASK AND/OR AIR TUBING? You may experience excessive condensation in your mask or air tubing. This may occur seasonally, particularly when the room temperature is low or cool air is circulating around the tube. Turn the control dial down to a lower setting until the condensation decreases. You may have to adjust your humidity setting from season to season. DO I HAVE TO USE DISTILLED WATER IN THE WATER CHAMBER? Using distilled water will maximize the life of the water chamber and reduce mineral deposits. See “Cleaning your HumidAire 3i” on page 11 for further details. FREQUENTLY ASKED QUESTIONS

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WHAT IF I STILL HAVE SYMPTOMS OF DRYNESS? If you still experience symptoms of dryness, then your humidity setting may be set too low to be effective. Gradually turn the humidity control dial up over a few nights until the symptoms disappear. If you are still experiencing symptoms of dryness, even after increasing the humidity setting, you may be breathing through your mouth. Mouth breathing or mouth leaks cause drying and irritation of the upper airway. If this is a problem, a full face mask or chin strap may help. Consult your clinician or equipment supplier for details.

CLEANING AND MAINTENANCE You should regularly carry out the cleaning and maintenance of the water chamber, cover and cover seal as described in this section.

DISASSEMBLING YOUR HUMIDAIRE 3i Please refer to the illustrations in section H of the illustration sheet.

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WARNING Beware of electrocution. Do not immerse your flow generator, docking station or power cord in water. Always unplug the device before cleaning and be sure that it is dry before plugging it back in.

1 Unplug the power cord from the power outlet (H-1). WARNING

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Take care when handling your HumidAire 3i. The water and the water chamber base may both be hot. Allow ten minutes for the heater plate and any excess water to cool (H-2).

2 Remove the water chamber from the docking station (H-3) and discard any excess water (H-4).

3 Detach the air tubing from the air outlet (H-5). 4 Gently flex one cover arm away and up from the docking station until the cover

detaches completely (H-6 to H-8). Peel the cover seal away from the cover (H-9).

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CAUTION Do not remove the tub plate from the water chamber.

CLEANING YOUR HUMIDAIRE 3i CAUTION

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Do not use any of the following to clean any part of the HumidAire 3i. These solutions may cause damage and reduce the life of the product. • bleach, chlorine-, alcohol- or ammonia-based solutions • moisturizing, antibacterial or glycerine based soaps • water softening and unapproved descaling agents. • Do not wash the water chamber in a dishwasher. •

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WATER CHAMBER DAILY

Wash the water chamber and tubing in warm water, using a mild detergent (see previous caution). Use the yellow cleaning plug to assist in the cleaning process (see steps 1 to 5 below).

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2

4

5

3

Rinse them thoroughly with clean water and allow them to dry away from direct sunlight. WEEKLY

Inspect the water chamber for wear and deterioration. Replace the water chamber if any component has cracked, become cloudy or pitted. Replace immediately if there is any leaking from the water chamber. If you notice white powder or deposits in the water chamber: i. Fill the water chamber to the maximum water level mark with a solution of one part vinegar to ten parts water. ii. Let the solution soak for ten minutes. iii. Discard the solution and rinse the water chamber with clean water. CLEANING AND MAINTENANCE

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COVER AND COVER SEAL Inspect the cover and cover seal weekly for wear and deterioration. Replace any damaged parts. When required, wash the cover and cover seal in warm water, using a mild detergent (see previous caution). Rinse them thoroughly with clean water and allow them to dry away from direct sunlight. DOCKING STATION Periodically wipe the outside of the docking station (including the connector seal) with a damp cloth.

REASSEMBLING YOUR HUMIDAIRE 3i Please refer to the illustrations in section I of the illustration sheet. Reassemble the parts when they are clean and dry.

1 Align the cover seal to the guides on the cover (I-1) and press along the edges to ensure it is fitted properly (I-2).

2 Put one cover arm into its pivot point on the docking station (I-3) and gently flex the other arm into its corresponding point (I-4 & I-5). The cover should be able to open and close freely while securely attached to the docking station.

3 Replace the water chamber in the humidifier docking station (I-6). SERVICING With normal use of a HUMIDAIRE 3i, the water chamber needs to be replaced every two years. This product (HUMIDAIRE 3i) should be inspected by an authorized ResMed Service Center 5 years from the date of manufacture. Prior to this, the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed. Applicable ResMed warranty details are provided with the device at the time of original supply. Of course, as with all electrical devices, if any irregularity becomes apparent, you should exercise caution and have the device inspected by an authorized ResMed Service Center.

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If there is a problem, try the following suggestions. If the problem cannot be solved, contact your equipment supplier or ResMed. Do not attempt to open the unit.

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WARNING

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TROUBLESHOOTING

Service and repair should only be performed by an authorized service agent.

Problem

Possible Cause

Solution

Device not working (no display on LCD screen and/or indicator light not lighting up)

Power cord is not plugged in properly.

Check that the power cord is plugged firmly into the power outlet and the switch (if available) is on at the outlet.

Faulty power outlet.

Try another power outlet.

Flow generator and docking station not connected correctly.

Check that the docking station is securely attached to the flow generator.

Indicator light periodically becomes brighter to indicate that the heating element is active.

• Your HumidAire 3i has a rapid heating element which allows very short heating times. Do not be concerned if the light only brightens very briefly.

Indicator light flickering

• Turn the dial to the setting to switch heated humidification off. The indicator light will remain lit to indicate standby mode. Indicator light is permanently dull and/or air does not feel warm

HumidAire 3i reflector (see illustration C-2a) is dirty.

Clean the reflector with a damp cloth.

Leaking water chamber

The water chamber may be damaged or cracked.

Contact your supplier for a replacement.

Cover is not attached correctly.

Make sure the cover is fitted correctly.

TROUBLESHOOTING

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Problem

Possible Cause

Solution

No/low air flow

The air tubing is not connected properly.

Connect the air tubing as described in “Setting Up your HumidAire 3i For Use” on page 6.

The air tubing is blocked, pinched or punctured.

Unblock or free the air tubing. Check the air tubing for punctures.

The flow generator is not working correctly.

See the Troubleshooting section in the flow generator manual.

The water chamber is overfilled.

Make sure that the water level is not above the maximum water level mark.

The cover is not latched correctly.

Make sure the cover is latched onto the docking station correctly.

The cover seal is not fitted correctly.

Make sure the cover seal is facing the right way up and fitted securely.

Condensation is forming in the air tube.

Turn the control dial down. Insulate the air tubing.

Water splashing on your face

The water chamber is overfilled.

Empty some water from the water chamber.

Condensation is forming in the air tube and mask.

Turn the control dial down. Insulate the air tubing.

Air does not feel moist

Air too moist

White powder or deposits in the water chamber

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The control dial is set too low.

Turn the control dial up.

HumidAire 3i heating element is not working.

Contact your equipment supplier.

Control dial is set too high.

Turn the control dial down.

High relative humidity in your room.

Adjust your humidity setting.

The water leaves scaly mineral deposits.

Use distilled water. To remove these mineral deposits, see “Cleaning your HumidAire 3i” on page 11.

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PERFORMANCE Maximum heater plate temperature: 185°F (85°C) Temperature cut-out: 199°F (93°C) Maximum output humidity: 95% relative humidity (control dial set to maximum setting, flow rate 50 L/min, ambient temperature of 68°F [20°C], ambient relative humidity of 40%). Maximum gas temperature: 106°F (41°C)

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TECHNICAL SPECIFICATIONS

DIMENSIONS (H X W X D) Docking station and water chamber: 4.6" x 6.7" x 8.3" (118 mm x 170 mm x 212 mm) WEIGHT Docking station and unfilled water chamber: 1.5 lb. (670 g) Water capacity to maximum fill line: 415 mL POWER SUPPLY Input range for ResMed S8 flow generator with HUMIDAIRE 3i: 100–240V, 50/60Hz; 110V, 400Hz; 2.5A <140 VA (110 W) (maximum power consumption). Instantaneous peak power consumption <340 VA. Actual average power consumption will vary, depending on factors such as temperature setting, set pressure, the use of accessories, height above sea level and ambient temperature. Maximum heater element power: 85 W. HOUSING CONSTRUCTION Docking station: Flame retardant engineering thermoplastic, plated cast aluminium. Water chamber: Injection molded plastic, stainless steel. ENVIRONMENTAL CONDITIONS Operating temperature: +41°F to +104°F (+5°C to +40°C) Operating humidity: 10–95% non-condensing Storage and transport temperature: -4°F to +140°F (-20°C to +60°C) Storage and transport humidity: 10–95% non-condensing IEC 60601-1 CLASSIFICATION Class II (double insulation) Type CF ELECTROMAGNETIC COMPATIBILITY Please refer to your flow generator user's manual for details. Note: The manufacturer reserves the right to change these specifications without notice.

TECHNICAL SPECIFICATIONS

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SYMBOLS WHICH APPEAR ON THE DEVICE Attention, consult accompanying documents Type CF equipment Class II equipment Hot surface Do not touch Maximum water level Do not remove the tub plate from the water chamber

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ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specified below from the date of purchase by the initial consumer. This warranty is not transferable. Product

Warranty Period

ResMed humidifiers, ResControl™, ResLink™, ResTraxx™

1 Year

ResMed flow generators

2 Years

Accessories, mask systems (including mask frame, cushion, headgear and tubing). Excludes single-use devices.

90 Days

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LIMITED WARRANTY

Note: Some models are not available in all regions. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; d) any damage caused by water being spilled on or into a flow generator. Warranty is void on product sold, or resold, outside the region of original purchase. Warranty claims on defective product must be made by the initial consumer at the point of purchase. This warranty is in lieu of all other express or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. ResMed shall not be responsible for any incidental or consequential damages claimed to have occurred as a result of 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 also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.

R001-307/2 05 06

LIMITED WARRANTY

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