ResMed H5i for S9 VPAP Auto BiPAP Machine with H5i Heated Humidifier User Guide

ResMed H5i for S9 VPAP Auto BiPAP Machine with H5i Heated Humidifier

WARNINGS

• ead 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 authorized ResMed service agent.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing 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.
• Take care when handling the H5i as the water/water tub may be hot. Allow 10 minutes for the heater plate and any excess water to cool.
• The H5i should only be connected or disconnected when the water tub is empty.
• Make sure that the water tub is empty before transporting the H5i.
• Do not operate the H5i on an aircraft as water may enter the device and air tubing during turbulence.
• Always place the H5i on a level surface below the level of the user to prevent the mask and tubing from filling with water.
• If liquids are inadvertently spilled into or on the H5i, unplug the device from the power outlet. Disconnect the H5i from the device and allow it to drain and dry before re-using.

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 VPAP Tx Clinical 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 distilled or deionized 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
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 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 or press .
   Note: Once therapy has started a treatment screen is displayed.

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.

Reprocessing the H5i and air tubing between patients

The H5i and air tubing should be reprocessed when used between patients. Cleaning and disinfection instructions are available from the ResMed website, www.resmed.com under Products and Service & Support. If you do not have internet access, please contact your ResMed representative.

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.

Technical specifications

• Maximum heater plate temperature 65°C
• Temperature cut-out 74°C
• Maximum gas temperature 41°C
• Nominal dimensions (L x W x H) Docking station and water tub: 153 mm x 145 mm x 86 mm
• Weight (Standard water tub) Docking station and unfilled water tub 0.69 kg
• Weight (Cleanable water tub) Docking station and unfilled water tub 0.79 kg
• Water capacity To maximum fill line 380 mL
• Docking station Flame retardant engineering thermoplastic, aluminum
• Cleanable water tub Injection molded plastic, stainless steel and silicone seal
• Standard water tub Injection molded plastic, aluminum and thermoplastic elastomer
• Operating temperature +5ºC to +35ºC
• Operating humidity 10–95% non-condensing
• Storage and transport temperature -20ºC to +60ºC
• Storage and transport humidity 10–95% non-condensing
• ClimateLine air tubing Flexible plastic and electrical components, 2 m, 15 mm inner diameter
• ClimateLineMAX air tubing Flexible plastic and electrical components, 1.9 m, 19 mm inner diameter
• Heated tubing temperature cut-out <41°C
• IEC 60601-1 classification Class II (double insulation), Type BF
• Electromagnetic compatibility Please refer to the S9 VPAP Tx Clinical Guide for details

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 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:

CPAP mask                                       RH output % Nominal system output AHa, BTPSb

pressure, cm H2O| Setting 3| Setting 6| Setting 3| Setting 6
4| 90| 100| 10| 18
10| 95| 100| 11.5| 21
20| 95| 100| 11| 18
25| 100| 100| 12| 13.5

• Absolute Humidity in mg/L.
• BTPS – Body Temperature Pressure Saturated

Symbols

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.

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 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; and d) any damage caused by water being spilled on or into an electronic device. Warranty is void on products sold, or resold, outside the region of original purchase. Warranty claims on defective products 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.

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Environmental policy - ResMed
• Legal disclaimers and intellectual property - ResMed

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