H5i User Guide Sept 2017

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E H5i™ HEATED HUMIDIFIER

User Guide 1

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English • Deutsch • Français • Italiano • Español • Português • Nederlands • Ελληνικά • Polski • Magyar • Русский • Türkçe • Česky • Slovensky

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5 Manufacturer: ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. See www.resmed.com for other ResMed locations worldwide. For patent information, see www.resmed.com/ip. S9, H5i and ClimateLine are trademarks of ResMed Pty Ltd. S9 and ClimateLine are registered in U.S. Patent and Trademark Office. © 2017 ResMed. 368881/2 2017-09

Global leaders in sleep and respiratory medicine

www.resmed.com

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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.

Contraindications The H5i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed. Please refer to the S9 Series User Guide for contraindications associated with CPAP or bilevel therapy.

Setup Refer to illustration A. 1. Align your H5i with your S9 and push them together until they click into place. 2. Connect the DC plug of the power supply unit to the rear of the S9. 3. Connect the power cord to the power supply unit. 4. Plug the other end of the power cord into the power outlet. 5. Connect one end of the air tubing firmly onto the air outlet. 6. Connect the assembled mask system to the free end of the air tubing.

Filling the water tub Refer to illustration B. 1. Slide the latch and lift open the flip lid. 2. Remove the water tub. 3. Fill the water tub (through the centre hole) with water up to the maximum water level mark (380 ml). 4. Return the water tub to the H5i. 5. Close the flip lid ensuring that it clicks into place.

Control panel Refer to illustration C. The control panel of your S9 devices includes the following items: 1. Start/Stop button: Starts or stops treatment 2. Home menu 3. LCD screen 4. Info menu: Allows you to view your sleep statistics 5. Setup menu: Allows you to make changes to settings 1 English

6. Push dial: Turning the dial allows you to scroll through the menu and change settings. Pushing the dial allows you to enter into a menu and confirm your choice.

Adjusting humidity level Refer to illustration D. Ranging from OFF to 6, you can adjust the humidity level at any time to find the setting that is most comfortable for you. To adjust your level of humidity: 1. From your HOME screen, turn (Push Dial) until the HUMIDITY LEVEL screen is displayed in blue. 2. Press . The selection is highlighted in orange. 3. Turn until the humidity level that you require is displayed. 4. Press to confirm your choice.

Warming the H5i The warm-up feature is used to pre-heat the water before starting treatment. To start warming: 1. Navigate to the humidity level icon. 2. Push and hold for three seconds. The Warming Up status bar is displayed. You can stop warmup at any time by pressing for at least three seconds. You can start treatment at any time by pressing (Start/Stop). Note: In order to assist the heater plate in cooling, your S9 device will continue to blow air for up to an hour after treatment has stopped. However, you can unplug the device from the power outlet at any time and allow the heater plate to cool without air flow.

Getting started 1. Make sure your S9 and H5i are connected and the water tub is filled to the maximum water level mark. 2. Adjust the humidification level if required. 3. Fit your mask as described in your mask user guide. 4. To start therapy, simply breathe into the mask and/or press . 5. Lie down and arrange the air tubing so that it is free to move if you turn in your sleep. 6. To stop treatment at any time, remove your mask and/or press . Notes: • If your clinician has enabled SmartStart your device will start automatically when you breathe into the mask and stop automatically when you remove the mask. • Once therapy has started a treatment screen is displayed.

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Cleaning and maintenance Disassembling the H5i Refer to illustration E. 1. Slide the latch. 2. Lift open the flip lid. 3. Remove the water tub. 4. Discard any excess water from the water tub. 5. Unclip all four side latches. 6. Pull apart the tub lid, plate and base. Daily: 1. Wash the disassembled tub lid, plate and base in warm water using a mild detergent. 2. Rinse thoroughly in clean water and allow them to dry away from direct sunlight. Note: The disassembled tub lid, plate and base may also be washed in a dishwasher on the delicate or glassware cycle (top shelf only). Monthly: 1. Peel the flip lid seal from the flip lid and wash it in warm water using a mild detergent. 2. Wipe the exterior of the H5i with a damp cloth and mild detergent. Reassembling the H5i: 1. Place the plate back onto the base ensuring that the maximum water level mark faces up. 2. Place the tub lid back onto the plate/base ensuring that the centre holes are aligned. 3. Clip all four side latches. 4. Fill the water tub and return the water tub to the H5i. 5. Close the flip lid ensuring that it clicks into place.

Troubleshooting 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 these devices. Problem/Possible cause

Solution

No display Power is not connected. The DC plug is partially inserted into the back of the device.

Ensure the power cable is connected and the power outlet (if available) is on. Fully insert the DC plug.

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Problem/Possible cause The S9 and H5i are not connected correctly.

Solution Ensure that the S9 and H5i are securely attached.

Insufficient air delivered from the device The S9 is not working correctly. Air tubing is not connected properly. Air tubing is blocked, pinched or punctured. The H5i flip lid is not latched correctly. The H5i flip lid seal is not fitted correctly. Incorrect air tubing selected.

See the Troubleshooting section of the S9 Series User Guide. Check air tubing. Unblock or free the air tubing. Check the air tubing for punctures. Close the flip lid ensuring that it clicks into place. Make sure the flip lid seal is facing the right way up and fitted securely. If you are using the SlimLine or Standard air tubing ensure that you have the correct air tubing selected via the menu.

Displays error message: Heated tube fault, replace tube Device has been left in a hot environment. There is a fault in your ClimateLine or ClimateLineMAX air tubing.

Allow to cool before re-use. Disconnect the power cord and then reconnect it to restart the device. Discontinue using your ClimateLine or ClimateLineMAX air tubing and contact your clinician/service provider. Use Standard or SlimLine tubing in the interim.

Displays error message: Humidifier fault, replace humidifier There is a fault in your H5i heated humidifier. Device has been left in a hot environment. Refilling the humidifier with cold water while humidifier is still hot after therapy. Filling the humidifier with ice cold water on a warm day or with hot water.

Discontinue using your H5i and contact your clinician/ service provider. Allow to cool before re-use. Disconnect the power cord and then reconnect it to restart the device. Allow the humidifier to cool before re-filling. Use room temperature water.

Displays error message: Tube blocked, please check your tube Air tubing is blocked.

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Check your air tubing and remove any blockages.

Problem/Possible cause

Solution

Displays error message: High leak, please check system setup and all connections There is excessive leak.

The H5i flip lid is not latched correctly.

Adjust position of mask and headgear. Air tubing is not connected properly. Connect firmly at both ends. Close the flip lid ensuring that it clicks into place.

Displays error message: Please close H5i flip lid, attach tube and press any key H5i flip lid is not closed. Air tubing is not connected properly.

Close the flip lid ensuring that it clicks into place. Connect firmly at both ends.

Water splashing on your face from the H5i The water tub is overfilled. Condensation is forming in the air tube and mask.

Check that the water level is below the maximum water level mark. Turn the H5i or relative humidity setting down via the menu.

Leaking water tub The water tub may be damaged or cracked. The cleanable water tub is not assembled correctly.

Contact your service provider for a replacement. Check for damage and reassemble the cleanable water tub correctly.

Air feels too warm/cold in the mask The temperature of the ClimateLine or ClimateLineMAX air tubing is set too high/low.

Turn up/down the heated tubing temperature via the menu.

Technical specifications Maximum heater plate temperature Temperature cut-out Maximum gas temperature Nominal dimensions (L x W x H) Weight (Standard water tub) Weight (Cleanable water tub) Water capacity Docking station

65°C 74°C 41°C Docking station and water tub: 153 mm x 145 mm x 86 mm Docking station and unfilled water tub 0.69 kg Docking station and unfilled water tub 0.79 kg To maximum fill line 380 mL Flame retardant engineering thermoplastic, aluminium 5 English

Cleanable water tub Standard water tub Operating temperature Operating humidity Storage and transport temperature Storage and transport humidity ClimateLine air tubing ClimateLineMAX air tubing

Injection molded plastic, stainless steel and silicone seal Injection molded plastic, aluminium and thermoplastic elastomer +5ºC to +35ºC 10–95% non-condensing -20ºC to +60ºC 10–95% non-condensing Flexible plastic and electrical components, 2 m, 15 mm inner diameter Flexible plastic and electrical components,1.9 m, 19 mm inner diameter  41°C Class II (double insulation), Type BF Please refer to the S9 Information Guide for details

Heated tubing temperature cut-out IEC 60601-1 classification Electromagnetic compatibility Notes: • The manufacturer reserves the right to change these specifications without notice. • The temperature and relative humidity settings displayed for ClimateLine or ClimateLineMAXare not measured values. • Check with your clinician/service provider before using the SlimLine air tubing with devices other than the S9 or H5i.

Humidifier performance The following settings have been tested at 22°C ambient temperature: Setting 3

Setting 6

Setting 3

Setting 6

4 10 20 25

90 95 95 100

100 100 100 100

10 11.5 11 12

18 21 18 13.5

a. AH - Absolute Humidity in mg/L. b. BTPS - Body Temperature Pressure Saturated.

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Nominal system output AHa, BTPSb

RH output %

CPAP mask pressure, cm H2O

Symbols The following symbols may appear on your H5i, ClimateLine or packaging. Caution;

Follow instructions for use; IP21 Protection against insertion of fingers and against

vertically dripping water; IP20 Not drip proof; Representative;

Keep dry;

Serial number; 93 C

European RoHS;

Batch code;

Not for use on more than one patient;

Disinfectable up to 93°C;

logo 2;

Manufacturer;

Lock/unlock;

China pollution control logo 1;

European Authorised Catalogue number; Maximum water level; China pollution control

Remove tub to fill;

Environmental information WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. These devices should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment. If you need information on these disposal systems, please contact your local waste administration. The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your ResMed device please contact your ResMed office, local distributor or go to www.resmed.com/environment.

Servicing The H5i device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the H5i be inspected and serviced by an authorised ResMed Service Centre if there is any sign of wear or concern with device function. Otherwise, service and inspection of the devices generally should not be required during the five year design life of the device.

Limited warranty ResMed Pty Ltd (hereafter ’ResMed’) warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below

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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 • Batteries for use in ResMed internal and external battery systems • Clip-type finger pulse sensors • CPAP and bilevel device data modules • Oximeters and CPAP and bilevel device oximeter adapters • Humidifiers and humidifier cleanable water tubs • Titration control devices • CPAP, bilevel and ventilation devices (including external power supply units) • Battery accessories • Portable diagnostic/screening devices

90 days

6 months 1 year

2 years

This warranty is only available to the initial consumer. It is not transferable. 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 organisation that has not been expressly authorised by ResMed to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; and d) any damage caused by water being spilled on or into an electronic device. 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 replaces all other expressed 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 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 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. 8 English

WARNINGS • • • • • • • • • • • •

Read the entire manual before using the device. Use the device only as directed by your physician or healthcare provider. Use the device only for the intended use as described in this manual. Advice contained in this manual should not supersede instructions given by the prescribing physician. If you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your ResMed Service Center. Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in water. In the event of a spill, disconnect the device from the power supply and let the parts dry. Always unplug the device before cleaning and make sure that all parts are dry before plugging in the device. Explosion hazard-do not use in the vicinity of flammable anesthetics. 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. Do not operate the H5i if it is not working properly or if any part of the device or H5i has been dropped or damaged. Do not leave long lengths of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping. Only ResMed air tubing and accessories should be used with the device. A different type of air tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of the treatment. Only use the ResMed 90W power supply units.

CAUTIONS • • • • • •

Do not open the device enclosure. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent. Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or antibacterial soaps or scented oils to clean the device, humidifier or air tubing. These solutions may cause damage and reduce the life of these products. The H5i should only be used with tubing or accessories recommended by ResMed. Connection of other delivery tubes or accessories could result in injury, or damage to the device. Do not open the H5i enclosure. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent. Do not overfill the water tub as water may enter the device and air tubing. Do not use any additives (eg, scented oils and perfumes). These may reduce the humidification output of the H5i and/or cause deterioration of the water tub materials. 9 English