RESMED VPAP IV Positive Airway Pressure Device User Guide

RESMED VPAP IV Positive Airway Pressure Device

Manufacturer:
ResMed Pty 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.
• Protected by patents: AU 697652, AU 699726, AU 713679, CA 2235939, EP 0661071, EP 0858352, JP 3638613, JP 4083154, US 6213119,
• US 6240921. Other patents pending.
• Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186, CN 200430121211.8, CN 200430121212.2, CN 200430121213.7, CN 200430121214.1, CN 200430121215.6, CN 200430121216.0, CN 200430121217.5, EU 269436, HK 0412901.9, JP 1248040, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406925, NZ 406926, NZ 406927, NZ 406928, US D544598, US D557406, US D557407, US D560795, US D561891, US D578204, US D585131, US D585540, US D590494, US D604830, US D614286, US D621031.
  SmartStart, TiCONTROL, VPAP, and Vsync are trademarks of ResMed Pty Ltd. SmartStart and VPAP are registered in U.S. Patent and Trademark Office.
  © 2011 ResMed. 268192/3 2011-07

Introduction

The VPAPTM IV and the VPAPTM IV ST are intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnoea (OSA), in the hospital or home.

Contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions:

• severe bullous lung disease
• pneumothorax or pneumomediastinum
• pathologically low blood pressure, particularly if associated with intravascular volume depletion
• dehydration
• cerebrospinal fluid leak, recent cranial surgery or trauma.

Adverse Effects
Patients should report unusual chest pain, severe headache or increased breathlessness to their 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.
  WARNING
  Read the entire manual before using these VPAP devices.

The VPAP System

Both the VPAP IV and the VPAP IV ST systems comprise the following elements:

• VPAP device

• 2 m air tubing

• Power cord

• Travel bag

• ResScan™ Data Card

• ResMed Oxygen Connector Port.

• Optional components include:

• 3 m air tubing

• DC/DC Converter 24V/50W.

• Masks
  The following ResMed mask systems are recommended for use with these devices:

• Humidifier
  If you are experiencing dryness of the nose, throat or mouth, the H4i heated humidifier is recommended for use with these VPAP devices.
  WARNING

  • Only ResMed mask systems are compatible for use with these VPAP devices.
  • Only the H4i is compatible for use with these VPAP devices.

• ResScan Data Card
  The ResScan Data Card may be used with these VPAP devices either to help your clinician to monitor your treatment or to provide you with updates to your device settings.

• Supplemental Oxygen
  The VPAP IV and VPAP IV ST are designed to be compatible with up to 15 L/min of supplemental oxygen. At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate.
  WARNING
  Always use the ResMed Oxygen Connector Port when adding supplemental oxygen at the flow generator outlet.

Using the VPAP IV and VPAP IV ST

Setting up your VPAP

1. Connect the power cord to the socket at the rear of your VPAP.

2. Plug the other end of the power cord into the power outlet.

3. Connect one end of the air tubing firmly onto the air outlet.

4. Connect the assembled mask system to the free end of air tubing.
   WARNING

   • Make sure the power cord and plug are in good condition and the equipment is not damaged.
   • Only ResMed air tubing and accessories should be used with the device. Do not use electrically conductive or antistatic hoses. A different type of air tubing or accessory may alter the pressure the patient receives, reducing the effectiveness of the treatment.
   •  Blocking the hose and/or air inlet of the device while in operation could lead to overheating of the device. CAUTION
   • Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord.
   • If you put the device on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air inlet.

Attaching a H4i Humidifier
The H4i humidifier attaches to the front of a VPAP IV or VPAP IV ST device to provide heated humidification. These devices automatically detect the presence of the H4i and no other accessories are required for its use. For more information on using your H4i, please refer to the H4i user guide.

WARNING

• Make sure that the water chamber is empty and thoroughly dried before transporting the H4i.
• When using the travel bag, always separate the VPAP unit and the H4i and place the H4i in its pouch.

How to Use the Control Panel

Using the Menus
The VPAP IV and VPAP IV ST provide a set of functions which are arranged in menus and submenus. Via the LCD screen, the menus and submenus allow you to view and change the settings for a particular function. To navigate and make selections:

1. Press or to scroll through items within a level.
2. Press to enter a submenu and to apply an option choice.
3. Press to navigate out of a menu or submenu and to exit without changing options.

Your clinician has preset the menu to either a standard menu or an advanced menu.
The following illustration summarises these views:

How to Select the Mask Type
Scroll to MASK and select . Press or until you see the setting you require. The following table shows the setting that should be selected for each mask:

SmartStart™
If your clinician has enabled SmartStart/Stop, your device will start automatically when you breathe into your mask and stop automatically when you take your mask off.

Starting Treatment

1. Make sure the power is on.
   The product name is displayed briefly on the LCD screen, then the standby (Ramp) screen appears. The key and LCD backlights also turn on.

2. Fit your mask as described in the mask user instructions.
   WARNING
   A mask should not be used unless your VPAP device is turned on and operating properly.

3. Alter the ramp time if required.

4. To start therapy, simply breathe into the mask or press .

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

6. After starting therapy, an introductory treatment screen will display:

Stopping Treatment
To stop treatment at any time, remove your mask and press . If your clinician has enabled SmartStart/Stop, simply remove your mask and treatment will end.

Note: SmartStart/Stop does not operate if:
• you have a Full Face Mask; or
• Leak Alert is enabled.

Using the Mask-Fitting feature
The VPAP IV and VPAP IV ST include a mask-fitting feature to help you fit your mask properly. The mask-fitting feature delivers air pressure for a three- minute period, prior to starting treatment, for checking and adjusting your mask fit to minimise leaks.
To use the mask-fitting feature:

1. Fit your mask as described in the mask user instructions.
2. Hold down for at least three seconds until air pressure delivery starts and the following screen appears:
   The LCD displays a mask-fit star rating from zero to five stars. Three to five stars indicates a good fit or better. Zero to two stars indicates that the mask needs to be adjusted.

Reminders on the VPAP LCD
Your clinician may have set your VPAP device to remind you about important events, such as when to replace your mask, when to insert your Data Card (if your device is Data Card enabled) and so on.The reminder message is displayed on the LCD and is visible if the device is not delivering therapy. The backlight on the LCD flashes when a message is displayed. Your clinician can set any of the following reminders on your LCD:

Smart Data
Smart Data menus only appear if enabled by the clinician. Your clinician can set any of the following Smart Data options:

Using the Data Card
If your clinician needs to review your treatment, they will ask you to use the Data Card to copy data from your VPAP device and return the card to them.

Copying Data onto a Data Card

1. 1 Switch on your VPAP and wait until you see the standby (Ramp) screen.

2. Hold the Data Card with the arrow facing up and insert it into the Data Card slot until it stops. Data copying starts automatically.
   The “Card Inserted Please Wait” message is displayed on the LCD while data is being copied. Copying takes up to 30 seconds. The “Copy Complete Remove Card” message is displayed on the LCD when copying has finished.

3. Remove the Data Card by gripping the end of the Data Card and pulling it out.

4. Store the Data Card in its protective folder when not in use.

5. Return the card in its protective folder to your clinician using a postal envelope.

Updating Settings on your VPAP
If your clinician has provided a Data Card with new device settings:

1. With the device in standby (Ramp) mode, insert the Data Card into the slot on the Data Card module. Updating will start automatically. The “Card Inserted Please Wait” message is displayed on the LCD while updating is in progress. Updating takes approximately five seconds. The “Settings Success Remove Card” message is displayed on the LCD if the settings were updated successfully.
   Note: This message only appears once. If you re-insert the Data Card after you have updated your settings, this message is not displayed.

2. Remove the Data Card from the VPAP device.

3. Store the Data Card in its protective folder when not in use.
   WARNING
   If your clinician has told you to use the Data Card to update the settings on your device and the “Settings Success” message does not appear, contact your clinician immediately.

Traveling with the VPAP IV and VPAP IV ST

• International Use
  Your VPAP flow generator has an internal power adapter that enables it to operate in other countries. It will operate on power supplies of 100–240V and 50–60Hz. No special adjustment is necessary, but you will require an approved power cord for that
  country.

• Use on an Aircraft
  Please consult the medical services department of your carrier if you intend to use your VPAP device on an aircraft.
  Note: You should not use your VPAP device while the aircraft is taking off or landing.

• Use with DC Power
  You must use a ResMed DC/DC Converter 24V/50W to connect your VPAP to a 12V or 24V DC power source. Contact your equipment supplier or ResMed for details.
  WARNING
  The device should not be connected to both AC and DC power sources simultaneously.

Cleaning and Maintenance

You should regularly carry out the cleaning and maintenance described in this section. Refer to your mask and humidifier manuals for detailed instructions regarding the care of those devices.

• Daily
  Disconnect the air tubing and hang it in a clean, dry place until next use.

• Weekly

  • Remove the air tubing from the VPAP device and the mask.
  • Wash the air tubing in warm water using mild detergent.
  • Rinse thoroughly, hang, and allow to dry.
  • Before the next use, reconnect the air tubing to the air outlet and mask.

• Monthly

  • Clean the exterior of the VPAP with a damp cloth and mild liquid soap.
  • Check the air filter for holes and blockage by dirt or dust.

• WARNING

  • Beware of electric shock. Do not immerse the unit or power cord in water. Always unplug the unit before cleaning and be sure it is dry before plugging back in.
  • The mask system and air tubing are subject to normal wear and tear. Inspect them regularly for damage.

Replacing the Air Filter
Replace the air filter every six months (or more often if necessary).

1. Remove the air filter cover at the back of the VPAP device.

2. Remove and discard the old air filter.

3. Insert a new filter with the blue-tinted side facing out from the device.

4. Replace the air filter cover.
   WARNING

   •  Do not wash the air filter. The air filter is not washable or reusable.
   •  The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure the air filter and air filter cover are fitted at all times.

Servicing
This device is intended to provide safe and reliable operation when operated and maintained in accordance with the instructions provided by ResMed. To ensure that your device continues to provide optimum performance it is recommended that this product be inspected by an authorised ResMed Service Centre five years from the date of purchase. 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 authorised ResMed service centre.

CAUTION

• Do not attempt to open the VPAP case. There are no user serviceable parts inside.
• Inspection and repair should only be performed by an authorised agent. Under no circumstances should you attempt to service or repair the flow generator yourself.

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 the device.

Technical Specifications

General Warnings and Cautions

Warnings

• Advice contained in this manual should not supersede instructions given by the prescribing physician.
• Use this device only as directed by your physician or healthcare provider.
• If you notice any unexplained changes in the performance of this 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 Centre.
• A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician. Only ResMed products are designed to be connected to the data communication port. Connecting other devices could result in injury, or damage to the VPAP device.
• These VPAP devices should only be used with masks (and connectors1) recommended by ResMed, or by a physician or respiratory therapist. A mask should not be used unless the VPAP device is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked.
• Explanation: These VPAP devices are intended to be used with special masks (or connectors*) which have vent holes to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask vent holes. However, when the device is not operating, insufficient fresh air will be provided through the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. This applies to most Positive Airway Pressure devices.
• In the event of power failure† or machine malfunction, remove the mask.
• These VPAP devices can be set to deliver pressures up to 25 cm H2O. In the unlikely event of certain fault conditions, pressures up to 40 cm H2O are possible.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the flow generator is not operating, so that unused oxygen does not accumulate within the flow generator enclosure and create a risk of fire.
• If the oxygen has been left on, turn off the device, then wait 30 minutes before turning on the device again.
• At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration varies, depending on the pressure settings, patient breathing pattern, mask, point of application and leak rate.
• Do not use the VPAP IV or VPAP IV ST if there are obvious external defects or unexplained changes in performance.
• Do not open the VPAP case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised service agent.
• Explosion hazard – do not use in the vicinity of flammable anesthetics.
• • Ports may be incorporated into the mask or in connectors that are near the mask.
• During partial (below rated minimum voltage) or total power failure, IPAP and EPAP pressures will not be delivered. When power is restored, operation will recommence with no change to settings.

Cautions

• At low pressures, the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing. Some rebreathing may occur.
• The airflow for breathing produced by this device can be as much as 11ºF (6ºC) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90ºF (32ºC).
• When AC mains power (100–240V AC) is not available, always use a ResMed DC/DC Converter 24V/50W. (The DC/DC Converter 24V/50W is available as an optional accessory. It is not supplied with all models.)
  Note: The above are general warnings and cautions. Specific warnings, cautions and notes appear with the relevant instructions in the manual.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity

Recommended separation distances between portable and mobile RF communications equipment and the VPAP series of devices

The VPAP device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the VPAP device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VPAP device as recommended below, according to the maximum output power of the communications equipment.

Guidance and manufacturer’s declaration – electromagnetic immunity
The VPAP device is intended for use in the electromagnetic environment specified below. The customer or the user of the VPAP device should assure that the device is used in such an environment.

• NOTE 1: Ut is the AC mains voltage prior to application of the test level.
• NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.
• NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VPAP device is used exceeds the applicable RF compliance level above, the VPAP device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VPAP device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Limited Warranty

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.

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:

• any damage caused as a result of improper use, abuse, modification or alteration of the product;

• repairs carried out by any service organisation that has not been expressly authorised by ResMed to perform such repairs;

• any damage or contamination due to cigarette, pipe, cigar or other smoke;

• 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.

Global leaders in sleep and respiratory medicine www.resmed.com

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed

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