VPAP™ Auto 25
VPAP™ ST
VPAP™ S
Positive AirwAy Pressure device
User Guide
English
VPAP™ Auto 25
VPAP™ ST
VPAP™ S
POSITIVE AIRWAY PRESSURE DEVICE
User Guide
English
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) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK
ResMed Offices Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Malaysia,
Mexico, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com
for contact details).
Protected by patents: AU 691200, AU 697652, AU 699726, AU 702820, AU 709279, AU 713679, AU 724589, AU 764761, EP 0651971, EP 0661071,
EP 0858352, EP 0920845, EP 0927538, EP 0934723, JP 3638613, US 5199424, US 5245995, US 5522382, US 5704345, US 6138675, US 6213119,
US 6240921, US 6363933, US 6367474, US 6425395, US 6502572, US 6591834, US 6675797, US 6705315, US 6745768, US 6817361, US 6988498,
US 7040317, US 7100608. 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. Other designs pending.
SmartStart, TiCONTROL, VPAP, and Vsync are trademarks of ResMed Ltd and SmartStart and VPAP are registered in U.S. Patent and Trademark
Office.
© 2008 ResMed Ltd. 268235/1 08 09
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Adverse Effects
The VPAP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Masks
Humidifier
ResScan Data Card
Supplemental Oxygen
Setting up your VPAP
Attaching a H4i Humidifier
SmartStart™
Using the Mask-Fitting feature
Using the Data Card
3
4
7
8
8
Daily
Weekly
Monthly
Replacing the Air Filter
Servicing
11
11
11
11
12
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Symbols Which Appear On The Device
15
General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Introduction
The VPAPTM Auto 25, VPAPTM ST and the VPAPTM S 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 to 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.
Introduction
1
Carry handle
Screen
Data Card
Module
Keypad
Air inlet
DC
AC
Air outlet
Masks
The following ResMed mask systems are recommended for use with these devices:
Mask Type
Name
Nasal Masks
•
•
•
•
•
Mirage Vista™ Nasal Mask
Ultra Mirage™ Nasal Mask
Ultra Mirage™ II Nasal Mask
Mirage Activa™ Nasal Mask
Mirage Micro™ Nasal Mask
Nasal Pillows Systems
Full Face Masks
•
•
•
Mirage Swift™ Nasal Pillows System
Mirage Swift™ II Nasal Pillows System
Swift™ LT Nasal Pillows System
•
•
•
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
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 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.
2
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
2
3
4
Connect the power cord to the socket at the rear of your VPAP.
Plug the other end of the power cord into the power outlet.
Connect one end of the air tubing firmly onto the air outlet.
Connect the assembled mask system to the free end of air tubing.
For information on assembling your mask, see your mask manual.
2
1
3
4
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.
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3
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 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
LCD screen
Keypad
Start/Stop Key
The control panel of your VPAP device includes an LCD screen which 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:
Key
Function
Starts or stops treatment. Extended hold for at least three
seconds starts the mask-fit feature.
Start/Stop
Allows you to increase settings options and scroll through the
menu.
Up
Allows you to decrease settings options and scroll through the
menu.
Down
Performs the function indicated by the guiding text displayed
above it on the LCD screen. Guiding text includes menu, change,
and apply.
Left
Performs the function indicated by the guiding text displayed
above it on the LCD screen. Guiding text includes exit and cancel.
Right
4
Using the Menus
The VPAP Auto 25, VPAP ST and VPAP S 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 within the Patient Menu:
1
2
3
Press
Press
or
to scroll through items within a level.
to enter a submenu and to apply an option choice.
Press
options.
to navigate out of a menu or submenu and to exit without changing
The following illustration summarizes the VPAP standard menu series:
WELCOME
>>>>>>
SETTLE: 20min
menu
RAMP: 10min
menu
ꢀ
ꢀ
VAuto mode
CPAP, S, ST & T modes
MASK: ULTRA
change
MASK: ULTRA
change
ꢀ
exit
exit
ꢀ
exit
exit
EXHALATION
EPR LEVEL: 1
change
ꢀ
change
ꢀ
USED:
006/002 days
0090hrs
exit
USED:
006/002 days
0090hrs
exit
SW: SX3650201
SW: SX3650201
ꢁ
exit
ꢁ
exit
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.
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5
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:
Settings
Mask
ULTRA
Ultra Mirage Nasal Mask
Ultra Mirage II Nasal Mask
MIR FULL
Mirage Liberty Full Face Mask
Mirage Quattro Full Face Mask
Ultra Mirage Full Face Mask
ACTIVA
SWIFT
Mirage Activa Nasal Mask
Mirage Swift Nasal Pillows System
Mirage Swift II Nasal Pillows System
Swift LT Nasal Pillows System
STANDARD
MIRAGE
Mirage Vista Nasal Mask
Mirage Micro Nasal Mask
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
2
3
4
On the standby (RAMP) screen, press
.
Press
Press
Press
until you see EPR LEVEL, then press
or until you see the setting that you require.
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
2
3
4
On the standby (SETTLE) screen, press
.
Press
Press
Press
until you see EXHALATION, then press
or until you see the setting that you require.
to save 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.
6
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
4
5
6
Alter the ramping/settling time if required.
To start therapy, simply breathe into the mask or press
.
Lie down and arrange the air tubing so that it is free to move if you turn in your sleep.
After starting therapy an introductory screen will display:
Mode and pressure display
S:RAMP
>>>>
4.0-10.0
PS 6.0
S mode
example
LK: 10L/min RR: 15
Leak and breath information
Inspiration information
MV: 10.2
VT: 680
S**TiMn
Ti 1.5s
TiMx 2.0
1: 1.6
SpO2: 98%
HR : 60
This screen only displays if
ResLink and an oximeter are
connected
exit
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:
•
you have a Full Face Mask; or
•
your clinician has enabled Leak Alert.
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7
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
2
Fit your mask as described in the mask user instructions.
Hold down
for at least three seconds until air pressure delivery starts and
the following screen appears:
MASK FIT:
excelnt
*****
Mask-fit star rating
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:
Message
Description
Action
INSERT
CARD
May appear if your device is
Data Card enabled.
Insert your Data Card and follow any
instructions that your clinician has given you.
When you have done this, the message will
disappear from the LCD. Pressing
will also remove the message.
(Ok)
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
Press
(Ok) to remove the message from
your LCD and contact your clinician/service
provider.
particular person or number.
8
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
2
Switch on your VPAP and wait until you see the standby (Ramp/Settle) screen.
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
4
5
Remove the Data Card by gripping the end of the Data Card and pulling it out.
Store the Data Card in its protective folder when not in use.
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
3
Remove the Data Card from the VPAP device.
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.
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9
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 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.
10
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
1
2
3
4
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
1
2
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.
Do not use bleach, chlorine, alcohol, or aromatic-based solutions,
moisturising 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).
1
Remove the air filter cover at the back of the VPAP device.
Air filter cover
2
3
4
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.
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11
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.
12
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.
Problem/Possible Cause
No display
Solution
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.
Air filter is dirty.
Wait for air pressure to build up or change ramp time.
Replace air filter.
Check air tubing.
Air tubing is not connected
properly.
Mask and headgear are not
positioned correctly.
Adjust position of mask and headgear.
Device does not start when you breathe into the mask
Breath is not deep enough to
trigger SmartStart/Stop.
Take a deep breath in and out through the mask.
There is excessive leak.
Adjust position of mask and headgear.
Air tubing not connected properly. Connect firmly at both ends.
Enable SmartStart/Stop.
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not
available if you are using a Full
Face Mask or if Leak Alert is
enabled.
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
Incompatible mask system being
used.
Only use equipment recommended by ResMed.
Pressure rises inappropriately
Talking, coughing or breathing in
an unusual manner.
Avoid talking with a nasal mask on, and breathe as normally as
possible.
Mask cushion is buzzing against
the skin.
Adjust the headgear.
Cushion seated incorrectly
causing excessive leak.
Adjust headgear or re-fit cushion.
Humidifier control dial set too
high, resulting in accumulation of
water in the air tubing.
Turn humidifier control down and empty the water from the air
tubing.
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13
Problem/Possible Cause
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
Solution
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 xxxxdefines an error)
Component failure.
Record 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.
Ensure that the Data Card is inserted with the arrow facing up
as far as it can go.
You may have removed the Data
Card before settings were copied
to the VPAP device.
Reinsert the Data Card and wait for the Settings Success
Remove Cardor Copy Complete Remove Cardmessage
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.
14
Technical Specifications
Operating pressure range
3 to 25 cm H O
2
Maximum single fault steady
state pressure
40 cm H O
2
Pressure measurement
tolerance
0.5 cm H O 4% of the measured reading
2
Flow measurement tolerance
VAuto mode
0.1 or 20% of reading, whichever is greater
4 to 25 cm H O (measured at the mask); Min EPAP: 4 cm H O;
2
2
Max IPAP: 25 cm H O; Pressure Support: 0 to 10 cm H O
2
2
S, ST and T modes
CPAP mode
IPAP: 4 to 25 cm H O (measured at the mask); EPAP: 3 to 25 cm H O
2
2
(measured at the mask); Pressure Support: 0 to 22 cm H O
2
4 to 20 cm H O (measured at the mask)
2
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)
Weight
4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm)
2.9 lb (1.3 kg)
Power supply
Input range 100–240V, 50–60Hz, 40VA (typical power consumption),
< 100VA (maximum power consumption)
Housing construction
Operating temperature
Operating humidity
Flame retardant engineering thermoplastic
41ºF to 95ºF (+5ºC to +35ºC)
10–95% non-condensing
Storage and transport
temperature
-4ºF to 140ºF (-20ºC to +60ºC)
Storage and transport humidity
Operating altitude
10–95% non-condensing
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
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
Flexible plastic, 1 x 6’6” (2 m)
Air tubing
Air outlet
The 22 mm conical air outlet complies with ISO 5356-1
Class II (double insulation), Type CF
IEC 60601-1 classification
Note: The manufacturer reserves the right to change these specifications without notice.
Symbols Which Appear On The Device
Attention, consult accompanying documents;
Drip proof;
Type CF equipment;
Manufacturer.
Dangerous voltage; Class II equipment;
Start/Stop;
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15
General Warnings and Cautions
Warnings
!
•
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 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.
•
•
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.
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.
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, operation will recommence with no change to settings.
16
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
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 serial adapter
RF emissions CISPR 11 with USB adapter
Harmonic Emissions IEC 61000-3-2
Class B
Class B
Class A
Complies
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.
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3
Warnings: The VPAP device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the VPAP device should be observed to verify normal operation in the configuration in
which it will be used. The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended.
They may result in increased emissions or decreased immunity of the VPAP device.
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 frequency of transmitter (m)
Rated maximum output
power of 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
0.1
1
0.17
0.37
1.17
0.04
0.11
0.35
1.11
0.07
0.22
0.7
10
3.69
11.70
2.21
7.0
100
3.50
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.
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17
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.
IEC60601-1-2 test
level
Immunity test
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
Mains power quality should be that of a typical
commercial or hospital environment.
Not Applicable
Surge
IEC 61000-4-5
1 kV differential
mode
1 kV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
2 kV common
mode
2 kV common
mode
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines.
<5% Ut (>95% dip in
Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95%dip in
Ut) 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
Mains 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.
IEC 61000-4-11
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.
Portable and mobile RF communications equipment
should be used no closer to any part of the VPAP
device, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
10 V/m
d = 1.17 √P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
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
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,
a
should be less than the compliance level in each
b
frequency range.
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.
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.
18
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.
Product
Warranty Period
ResMed humidifiers, ResControl™, ResLink™, ResTraxx™
ResMed flow generators
1 Year
2 Years
90 Days
Accessories, mask systems (including mask frame, cushion,
headgear and tubing). Excludes single-use devices.
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.
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19
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