RESMED S 10 Positive Airway Pressure Device User Guide

VPAP™ Auto 25
VPAP™ ST
VPAP™ S
Positive AirwAy Pressure device
User Guide

Introduction

The VPAP TM Auto 25, VPAP TM ST, and the VPAPTM ST are indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). They are intended for home and hospital use.
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.
CAUTION (USA ONLY)
Federal law restricts these devices from sale by or on the order of a physician.

The VPAP System

The VPAP Auto 25, VPAP ST, and the VPAP S comprise the following elements:

• VPAP device

• 6’6” (2 m) air tubing

• Power cord

• Travel bag

• ResScan™ Data Card.
  Optional components include:

• 9’9” (3 m ) air tubing

• DC/DC converter 24V/50W

• ResMed Oxygen Connector Port.

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

• Ultra Mirage™ Nasal Mask
• Ultra Mirage™ II Nasal Mask
• Mirage Activa™ Nasal Mask
• Mirage Micro™ Nasal Mask
Nasal Pillows Systems| • Mirage Swift™ Nasal Pillows System
• Mirage Swift™ II Nasal Pillows System
• Swift™ LT Nasal Pillows System
Full Face Masks| • Mirage™ Liberty Full Face Mask
• Mirage™ Quattro Full Face Mask
• Ultra Mirage™ Full Face Mask

For information on using masks, see your mask manual. For the latest available masks, see www.resmed.com.
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 have been validated for use with these VPAPdevices.
• 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 Auto 25, VPAP ST, and VPAP S are designed to be compatible with the following levels of supplemental oxygen usage:

• Up to 4 L/min in VAuto mode
• Up to 15 L/min in CPAP, S, ST, and T modes.

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 Auto 25, VPAP ST & VPAP S

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 the air tubing. For information on assembling your mask, see your mask manual.

WARNING!

• Make sure the power cord and plug are in good condition and the equipment is not damaged.
• Only ResMed air tubing should be used with the device. A different type of air tubing may alter the pressure you actually receive, reducing the effectiveness of your 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 an H4i Humidifier
The H4i humidifier attaches to the front of a VPAP Auto 25, VPAP ST, or VPAP S 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

The control panel of your VPAP device includes an LCD screen that displays the menus and treatment screens as well as a keypad for navigating through the menus and delivering treatment. The keypad has the following keys:

three seconds starts the mask-fit feature.
Up| Allows you to increase settings options and scroll through the menu.
Down| Allows you to decrease settings options and scroll through the menu.
Left| Performs the function indicated by the guiding text displayed above it on the LCD screen. The guiding text includes menu, change, and apply.
Right| Performs the function indicated by the guiding text displayed above it on the LCD screen. The guiding text includes exit and cancel.

Using the Menus
The VPAP Auto 25, VPAP ST, and VPAP S provide a set of functions that 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 within the Patient Menu:

1. Press r 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 exit without changing options.

The following illustration summarizes the VPAP standard menu series: Notes:

• The Ramp or Settling screens are only available if Max Ramp/Max Settle has been set by the clinician.
• The Exhalation screen will only appear if patient access is enabled by a clinician in VAuto mode.
•  The EPR Level screen will only appear if patient access is enabled by a clinician in CPAP mode.

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:

Ultra Mirage II Nasal Mask
MIR FULL|  Mirage Liberty Full Face Mask
Mirage Quattro Full Face Mask
Ultra Mirage Full Face Mask
ACTIVA| Mirage Activa Nasal Mask
SWIFT| Mirage Swift Nasal Pillows System
Mirage Swift II Nasal Pillows System
Swift LT Nasal Pillows System
STANDARD| Mirage Vista Nasal Mask
Mirage Micro Nasal Mask
MIRAGE| Mirage Nasal Mask

How to change the EPR level (CPAP mode)
Expiratory Pressure Relief (EPR) can be used to improve your comfort level when breathing out during treatment. If patient access is enabled by the clinician you can change the EPR level. There are four settings: OFF; 1 (lowest EPR); 2; and 3 (highest EPR).

1. On the standby (RAMP) screen, press.
2. Press until you see EPR LEVEL, then press
3.  Press ****or until you see the setting that you require.
4.  Press to save the setting.

How to change the Exhalation rate (VAuto mode)
If patient access is enabled by the clinician, you can adjust the Exhalation rate so that the rate of pressure drop is at a level that is most comfortable for you. There are three
settings: Fast; Medium; and Slow.

1. On the standby (SETTLE) screen, press
2. Press until you see EXHALATION, then press
3. Press ****or until you see the setting that you require.
4. Press to saves the setting.

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/Settle) 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 ramping/settling 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 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 will not work if:

• Do you have a Full Face Mask; or
•  your clinician has enabled Leak Alert.

Using the Mask-Fitting feature
The VPAP Auto 25, VPAP ST, and VPAP S 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 minimize 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:

Card and follow any instructions that your clinician has given you. When you have done this, the message will disappear from the LCD. Pressing (Ok) will also remove the message.
REPLACE MASK| Reminds you that your mask is due for replacement.| Press (Ok) to remove the message from your LCD and replace your mask with a new one.
CALL PROVIDER| Reminds you to contact your clinician; for example to discuss your therapy.| Press (Ok) to remove the message from your LCD and contact your clinician/service provider.
REPLACE FILTER| Reminds you to replace the air filter on your device.| Press (Ok) to remove the message from your LCD and replace the air filter.
SERVICE DUE| Reminds you to return your device for service.| Press (Ok) to remove the message from your LCD and contact your clinician/service provider.
Customized messages| Your clinician may also set reminders for other reasons; for example, to call a particular person or number.| Press (Ok) to remove the message from your LCD and contact your clinician/service provider.

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. Switch on your VPAP and wait until you see the standby (Ramp/Settle) 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/Settle) 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 Auto 25, VPAP ST & VPAP S
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. The VPAP Auto 25, VPAP ST and VPAP S comply
with US FCC Part 15, Class B requirements if no external data cables are used.
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 12Vor 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 the next use.
Weekly

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

Monthly

1. Clean the exterior of the VPAP with a damp cloth and mild liquid soap.
2. 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.
• Do not use bleach, chlorine, alcohol, aromatic-based solutions, moisturizing or antibacterial soaps, or scented oils to clean the air tubing or the device. These solutions may cause hardening and reduce the life of the product.

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

• Remove the air filter cover at the back of the VPAP device.
• Remove and discard the old air filter.
• Insert a new filter with the blue-tinted side facing out from the device
• 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 product should be inspected by an authorized ResMed service center five 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.
****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 authorized 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.

No display
Power is not connected.| Ensure the power cable is connected and the power switch (if available) is on.
Insufficient air delivered from the VPAP device
Ramp or Settling time is in use. The air filter is dirty. Air tubing is not connected properly.
Mask and headgear are not positioned correctly.| Wait for air pressure to build up or change ramp time. Replace the air filter.
Check air tubing. Adjust the position of the mask and headgear.
The device does not start when you breathe into the mask
The breath is not deep enough to trigger SmartStart/Stop. There is an excessive leak. SmartStart/Stop is disabled. Note: SmartStart/Stop is not available if you are using a Full Face Mask or if Leak Alert is enabled.| Take a deep breath in and out through the mask. Adjust the position of the mask and headgear.  Air tubing is not connected properly. Connect firmly at both ends. Enable SmartStart/Stop.
The device does not stop when you remove your mask
SmartStart/Stop is not enabled. Note: SmartStart/Stop is not available if you are using a Full Face Mask or if Leak Alert is enabled.| Enable SmartStart/Stop.
SmartStart/Stop is enabled but the flow generator does not stop automatically when you remove your mask
An incompatible mask system is being used.| Only use equipment recommended by ResMed
Pressure rises inappropriately
Talking, coughing, or breathing in an unusual manner. The Mask cushion is buzzing against
the skin. Cushion seated incorrectly causing an excessive leak. The humidifier control dial was set too high, resulting in an accumulation of water in the air tubing.| Avoid talking with a nasal mask on, and breath as normally as
possible. Adjust the headgear. Adjust headgear or re-fit cushion.
Turn the humidifier control down and empty the water from the air
tubing.
Displays error message: Check tube!! Key if done
The air tubing is loose or blocked.| Check that the air tubing is connected securely to your mask and the air outlet. Press the Start/Stop key to restart the device. If this does not clear the message, disconnect the power cord and then reconnect it to restart the device.
Displays error message: Exxxx Call Service (where XXXX defines an error)
Component failure.| Record the error number and contact your ResMed service center.
Displays error message: HIGH LEAK!!! Adjust Mask
You have experienced excessively high leak levels for more than 20 seconds.| Check that your air tubing is connected properly.  Adjust headgear.
The following message is displayed on the LCD after you try to update settings or copy data to the Data Card: Card Error Remove Card
Data Card is not inserted correctly. You may have removed the Data Card before settings were copied to the VPAP device.| Ensure that the Data Card is inserted with the arrow facing up
as far as it can go. Reinsert the Data Card and wait for the Settings Success Remove Card or Copy Complete Remove Card message
to appear on the LCD.
The following message is displayed on the LCD after you try to update the settings using the Data Card: Settings Invalid Remove Card
The identification details on the Data Card do not match the details on your device.| Contact your clinician/service provider immediately.
The following message is displayed on the LCD after you try to update the settings using the Data Card: Settings Error Remove Card
There is a data error on the Data Card.| Contact your clinician/service provider immediately.
The following message is NOT displayed on the LCD after you try to update the settings using the Data Card: Settings Success Remove Card
The settings were not updated.| Contact your clinician/service provider immediately.

Technical Specifications

IPAP: 25 cm H2O; Pressure Support: 0 to 10 cm H2O
S, ST, and T modes| IPAP: 4 to 25 cm H2O (measured at the mask); EPAP: 3 to 25 cm H2O (measured at the mask); Pressure Support: 0 to 22 cm HO
CPAP mode| 4 to 20 cm H2O (measured at the mask)
DECLARED DUAL-NUMBER NOISE| EMISSION VALUES in accordance with ISO 4871:
Sound pressure level| 26 dBA with uncertainty of 2 dBA as measured according to
ISO 17510-1: 2002 28 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007
Sound power level| 36 dBA with uncertainty of 2 dBA as measured according to
ISO 17510-1:2007
Dimensions (L x W x H)| 4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm)
Weight| 2.9 lb (1.3 kg)
Power supply| Input range 100–240V, 50–60Hz, 40VA (typical power consumption), < 100VA (maximum power consumption)
Housing construction| Flame retardant engineering thermoplastic
Operating temperature| 41ºF to 95ºF (+5ºC to +35ºC)
Operating humidity| 10–95% non-condensing
Storage and transport temperature| -4ºF to 140ºF (-20ºC to +60ºC)
Storage and transport humidity| 10–95% non-condensing
Operating altitude| Sea level to 8,500’ (2,600 m)
Supplemental oxygen| Recommended maximum supplemental oxygen flow:
4 L/min (VAuto mode); 15 L/min (CPAP, S, ST and T modes)
Electromagnetic compatibility| The product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial, and light industry environments
Air filter| Two-layered, powder-bonded, polyester non-woven fiber
Air tubing| Flexible plastic, 1 x 6’6” (2 m)
Air outlet| The 22 mm conical air outlet complies with ISO 5356-1
IEC 60601-1 classification| Class II (double insulation), Type CF

Note : The manufacturer reserves the right to change these specifications without notice.
Symbols Which Appear On The Device

Class II equipment;

General Warnings and Cautions

Warnings

• The advice contained in this manual should not supersede instructions given by the prescribing physician.

• 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 connectors ) 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 a 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 models of PAP devices. 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.

• Do not use the VPAP Auto 25, VPAP ST, or VPAP S 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 authorized service agent.

• Explosion hazard – do not use in the vicinity of flammable anesthetics.

• In the event of power failure
  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 output converter. (The DC/DC converter 24V/50W output converter is available as an optional accessory.)

Note : The above are general warnings and cautions. Specific warnings cautions and notes appear with the relevant instructions in the manual.
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, therapy pressures will not be delivered. When power is restored, the operation will recommence with no change to settings.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity
The VPAP Auto 25, VPAP ST, and VPAP S devices are 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.

Emissions test| Compliance| Electromagnetic environment – guidance
---|---|---
RF emissions CISPR11| Group 1| The VPAP device uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11 with a serial adapter| Class B| The VPAP device is suitable for use in all
establishments, including domestic establishments and those directly connected to
the public low-voltage network that supplies
buildings used for domestic purposes.
RF emissions CISPR 11 with USB adapter| Class B
Harmonic Emissions IEC 61000-3-2| Class A
Voltage Fluctuations/Flicker Emissions IEC 61000-3-3| Complies

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.

| Separation distance according to the frequency of the transmitter (m)
---|---
The rated maximum  output power of the transmitter (W)| 150 kHz to 80 MHz d = 1.17 √P| 80 MHz to 800 MHz d = 0.35 √P| 800 MHz to 2.5 GHz d = 0.7 √P
0.01| 0.17| 0.04| 0.07
0.1| 0.37| 0.11| 0.22
1| 1.17| 0.35| 0.7
10| 3.69| 1.11| 2.21
100| 11.70| 3.50| 7.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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.

Immunity test| IEC60601-1-2 test
level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Electrostatic
discharge (ESD)
IEC 61000-4-2| ±6 kV contact
±8 kV air| ±6 kV contact
±8 kV air| Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4| ±2 kV for power
supply lines
±1 kV for input/
output lines| ±2 kV
Not Applicable| Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5| ±1 kV differential
mode
±2 kV common
mode| ±1 kV differential Nmode ±2 kV common mode| Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
IEC 61000-4-11| <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip inUt) for 25 cycles<5% Ut >95%dip inUt) for 5 sec| < 12V (>95% dip in 240V) for 0.5 cycle 96V (60% dip in 240V) for 5 cycles 168V (30% dip in 240V) for 25 cycles <12V (>95%dip in
240V) for 5 sec| The main power quality should be that of a typical commercial or hospital environment.
If the user of the VPAP device requires continued operation during power mains interruptions, it is recommended that the VPAP device be powered from an uninterruptible power source.
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms 150 kHz to 80 MHz10 V/m80 MHz to 2.5 GHz| 3 Vrms 10 V/m| Portable and mobile RF communications equipment
should be used no closer to any part of the VPAP
the device, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.17 √P
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each
frequency range.b Interference may occur in the vicinity of equipment marked with this symbol
---|---|---|---

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.

• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts 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.

• Over the frequency range of 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.

Accessories, mask systems (including mask frame, cushion, headgear, and tubing). Excludes single-use devices.| 90 Days

Note: Some models are not available in all regions.
If the product fails under conditions of normal use, ResMed will repair or replace, it 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 organization that has not been expressly authorized 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 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 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.

References

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

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