S9™ Auto 25 Information Guide

S9™ Auto 25
POSITIVE AIRWAY PRESSURE DEVICE
Information Guide
English
English
Please read the entire Information and Welcome Guides before using your device.
Indications for use
The S9 Auto 25 is indicated for the treatment of obstructive sleep apnoea (OSA) in patients weighing
more than 30 kg. The S9 Auto 25 is intended for home and hospital use.
Contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following preexisting 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.
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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 enclosure.
Problem/Possible cause
Solution
No display
Power is not connected.
Ensure the power cable is connected and the power outlet (if
available) is on.
The DC plug is partially inserted
into the back of the device or
inserted too slowly.
Fully insert the DC plug.
Insufficient air delivered from the Auto 25 device
Ramp time is in use.
Wait for air pressure to build up or change ramp time.
Air filter is dirty.
Replace air filter.
Air tubing is not connected
properly.
Check air tubing.
Air tubing is blocked, pinched or
punctured.
Unblock or free the air tubing. Check the air tubing for punctures.
Mask and headgear are not
positioned correctly.
Adjust position of mask and headgear.
Incorrect air tubing selected.
If you are using the SlimLine, Standard or 3m air tubing ensure that
you have the correct air tubing selected via the menu.
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.
Note: If Leak Alert is enabled,
an audible alert is activated and
a high leak message is
displayed.
Adjust position of mask and headgear.
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Air tubing not connected properly. Connect firmly at both ends.
Problem/Possible cause
Solution
Enable SmartStart/Stop.
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not
available if Leak Alert is enabled.
Device does not stop when you remove your mask
Enable SmartStart/Stop.
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not
available if Leak Alert is enabled.
SmartStart/Stop is enabled but the device does not stop automatically when you remove your
mask
Incompatible mask system
being used.
Only use equipment recommended by ResMed.
The patient is using a nasal
pillows mask with a set
pressure less than 7 cm H2O.
Disable SmartStart/Stop
Pressure rises inappropriately
Talking, coughing or breathing in Avoid talking with a nasal mask on, and breathe as normally as
an unusual manner.
possible.
Mask cushion is buzzing against
the skin.
Adjust the headgear.
Cushion seated incorrectly
causing excessive leak.
Adjust headgear or re-fit cushion.
Displays error message: High temperature fault, refer to user manual
Device has been left in a hot
environment.
Allow to cool before re-use. Disconnect the power cord and then
reconnect it to restart the device.
Air filter is blocked.
Replace your air filter. Disconnect the power cord and then
reconnect it to restart the device.
Air tubing is blocked.
Check your air tubing and remove any blockages. Disconnect the
power cord and then reconnect it to restart the device.
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Problem/Possible cause
Solution
Humidifier setting is too high,
resulting in accumulation of
water in the air tubing.
Turn the humidifier setting down and empty the water from the air
tubing.
Displays error message: Check ResMed 30/90W Power Supply Unit and fully insert the
connector
The DC plug is partially inserted
into the back of the device or
inserted too slowly.
Fully insert the DC plug.
A non-ResMed power supply
unit is connected to the device.
Remove the power supply unit and replace with a ResMed power
supply unit.
The power supply unit is being
covered by bedding.
Make sure that the power supply unit is free from bedding, clothes
or other objects that could cover it.
Displays error message: Tube blocked, please check your tube
Air tubing is blocked.
Check your air tubing and remove any blockages. Disconnect the
power cord and then reconnect it to restart the device.
Displays error message: High leak, please check system setup and all connections
There is excessive leak.
Adjust position of mask and headgear.
Air tubing is not connected properly. Connect firmly at both ends.
The following message is displayed on the LCD after you try to update settings or copy data to
the SD card: Card error, please remove SD card and contact service provider
SD card is not inserted correctly. Ensure that the SD card is inserted correctly.
You may have removed the SD
card before settings were
copied to the device.
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Reinsert the SD card and wait for the Home screen or the
"Settings updated successfully, press any key" message to
appear on the LCD.
Note: This message only appears once. If you re-insert the SD card
after you have updated your settings, the message will not be redisplayed.
Problem/Possible cause
Solution
The following message is NOT displayed on the LCD after you try to update the settings using
the SD card: Settings updated successfully, press any key
The settings were not updated.
Contact your clinician/service provider immediately.
General technical specifications
Power supply
Environmental
conditions
Aircraft use
90W power supply unit
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use
Typical power consumption: 70W (80VA)
Maximum power consumption: 110W (120VA)
30W power supply unit
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use
Typical power consumption: 20W (40VA)
Maximum power consumption: 36W (75VA)
90W DC/DC converter
Nominal inputs: 12V, 24V
Typical power consumption: 70W
Maximum power consumption: 110W
Operating temperature: +5°C to +35°C
Note: The air flow for breathing produced by this therapy device can be higher
than the temperature of the room. Under extreme ambient temperature
conditions (40ºC) the device remains safe.
Operating humidity: 10 to 95% non-condensing
Operating altitude: Sea level to 2,591m
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: 10 to 95% non-condensing
ResMed confirms that the device/s meets the Federal Aviation Administration
(FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air
travel.
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Electromagnetic
compatibility
IEC 60601-1
classification
Product complies with all applicable electromagnetic compatibility requirements
(EMC) according to IEC60601-1-2, for residential, commercial and light industry
environments.
It is recommended that mobile communication devices are kept at least 1 m
away from the device.
Information regarding the electromagnetic emissions and immunity of this
ResMed device can be found on www.resmed.com, on the Products page
under Service and Support. Click on the PDF file for your language.
Class II (double insulation), Type BF
Auto 25 technical specifications
Pressure and
flow state
Mode reading
Physical
Air filter
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Operating pressure range (measured at the mask): 4-20 cm H2O (CPAP); 4-25 cm
H2O (VPAP)
Maximum single fault steady state pressure: 30 cm H2O - if pressure exceeded
for > 6 sec; 40 cm H2O - if pressure exceeded for >1 sec
Pressure measurement tolerance: ±0.5 cm H2O ± 4% of the measured reading
Flow measurement tolerance: ±6 L/min or 10% of reading, whichever is greater,
at 0 to 150 L/min positive flow
CPAP mode
Set Pressure: 4 to 20 cm H2O
VAuto mode
Min EPAP: 4 cm H2O; Max IPAP: 25 cm H2O; Pressure support: 0 to 10 cm H2O.
Nominal dimensions (L x W x H): 153 mm x 140 mm x 86 mm
Weight: 835 g
Housing construction: Flame retardant engineering thermoplastic
Air outlet: 22 mm conical air outlet (complies with ISO 5356-1:2004)
Hypoallergenic air filter: Acrylic and polypropylene fibers in a polypropylene
carrier
Standard air filter: Polyester non-woven fiber
Sound
DECLARED
DUAL-NUMBER
NOISE EMISSION
VALUES in
accordance with
ISO 4871:1996
Supplemental
oxygen
Pressure level (CPAP mode)
With SlimLine air
26 dBA with uncertainty of 2 dBA as measured according
tubing:
to EN ISO 17510-1:2009
With Standard air
27 dBA with uncertainty of 2 dBA as measured according
tubing:
to EN ISO 17510-1:2009
With either SlimLine 28 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
or Standard air
tubing and H5i:
Power level (CPAP mode)
With SlimLine air
34 dBA with uncertainty of 2 dBA as measured according
tubing:
to EN ISO 17510-1:2009
With Standard air
35 dBA with uncertainty of 2 dBA as measured according
tubing:
to EN ISO 17510-1:2009
With either SlimLine 36 dBA with uncertainty of 2 dBA as measured according
or Standard air
to EN ISO 17510-1:2009
tubing and H5i:
Recommended maximum supplemental oxygen flow: 4 L/min
Air tubing technical specifications
Air tubing
ClimateLine heated air tubing
Material
Length
Inner diameter
Flexible plastic and electrical 2 m
15 mm
components
Flexible plastic and electrical 1.9 m
19 mm
ClimateLineMAX heated air
components
tubing
SlimLine air tubing
Flexible plastic
1.8 m
15 mm
Standard air tubing
Flexible plastic
2m
19 mm
3 m air tubing
Flexible plastic
3m
19 mm
Heated air tubing temperature cut-out: ≤ 41°C
Notes:
• The manufacturer reserves the right to change these specifications without notice.
• The temperature and relative humidity settings displayed for Climate Control are not measured
values.
• Check with your clinician/service provider before using the SlimLine air tubing with devices other
than the S9 or H5i.
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•
The electrical connector end of the heated air tubing is only compatible with the H5i air outlet and
should not be fitted to the device or mask.
Humidifier performance
The following settings have been tested at 22°C ambient temperature:
Mask pressure
RH output %
Nominal system output AHa, BTPSb
cm H2O
Setting 3
Setting 6
Setting 3
Setting 6
4
90
100
10
18
10
95
100
11.5
21
20
95
100
11
18
25
100
100
12
13.5
a. AH - Absolute Humidity in mg/L.
b. BTPS - Body Temperature Pressure Saturated.
Pneumatic flow path
1. Inlet filter
2. Blower
3. Air tubing
4. Mask
Flow (maximum) at set pressures
The following are measured at the end of the specified air tubing:
Pressure, cm H2O
Auto 25 and
Auto 25, H5i and
Auto 25 and
Standard air
Standard air
SlimLine air
tubing, L/min
tubing, L/min
tubing, L/min
4
8
12
16
20
25
8
200
200
200
200
190
180
170
170
170
170
170
161
195
190
184
175
168
144
Auto 25, H5i and
ClimateLine
heated air tubing,
L/min
170
170
170
170
161
125
Displayed values
Value
Range
Pressure sensor at air outlet
Pressure
4 to 25 cm H2O
Accuracy
Display resolution
±0.5 cm H2O (±4% of 0.1 cm H2O
measured value)
Flow derived valuesa
b
Leak
0–200 L/min
1 L/min
Tidal volume
0–4000 mL
±10%
1 mL
Respiratory rate
0–50 BPM
±1 BPM c
1 BPM
Minute ventilation
0–30 L/min
±10%
0.1 L/min
Ti Avg
0–4.0 sec
±10%
0.2 sec
a. Results may be inaccurate in the presence of leaks or supplemental oxygen.
b. The displayed values are estimates. They are provided for trending purposes only.
c. Results may be inaccurate if the tidal volume is below 50 mL.
Pressure accuracy
Maximum static pressure variation at 10 cm H2O according to EN ISO 17510-1:2009
Standard air tubing
SlimLine air tubing
Without H5i
9.89 cm H2O to 9.97 cm H2O
9.76 cm H2O to 9.87 cm H2O
With H5i
9.82 cm H2O to 9.98 cm H2O
9.78 cm H2O to 9.88 cm H2O
Maximum dynamic pressure variation according to EN ISO 17510-1:2009
Pressure (cm H2O)
4
8
12
16
20
25
10 BPM
15 BPM
20 BPM
Auto 25 and Standard air tubing without H5i / Auto 25 and Standard air
tubing with H5i
0.18 / 0.18
0.30 / 0.30
0.51 / 0.51
0.21 / 0.20
0.26 / 0.24
0.38 / 0.36
0.21 / 0.20
0.26 / 0.23
0.34 / 0.31
0.22 / 0.21
0.27 / 0.26
0.36 / 0.33
0.23 / 0.22
0.26 / 0.28
0.38 / 0.35
0.30 / 0.31
0.54 / 0.50
0.74 / 0.71
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Pressure (cm H2O)
4
8
12
16
20
25
10 BPM
15 BPM
20 BPM
Auto 25 and SlimLine air tubing without H5i / Auto 25 and SlimLine air
tubing with H5i
0.22 / 0.20
0.28 / 0.29
0.47 / 0.53
0.23 / 0.19
0.32 / 0.29
0.41 / 0.42
0.22 / 0.21
0.35 / 0.29
0.41 / 0.45
0.22 / 0.23
0.41 / 0.33
0.44 / 0.50
0.24 / 0.27
0.37 / 0.34
0.48 / 0.50
0.31 / 0.31
0.50 / 0.54
0.78 / 0.84
Symbols
The following symbols may appear on your product or packaging.
Caution;
Read instructions before use;
against vertically dripping water;
equipment;
Start/Stop;
Catalogue number;
Not drip proof;
Manufacturer;
Serial number;
China pollution control logo 1;
Authorised Representative;
Protection against insertion of fingers and
Type BF equipment;
European RoHS;
Direct current;
China pollution control logo 2;
Class II
Batch code;
Lock/unlock;
European
Keep Dry;
Environmental information
WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic
equipment. This device should be disposed of separately, not as unsorted municipal waste. To
dispose of your device, you should use appropriate collection, reuse and recycling systems available
in your region. The use of these collection, reuse and recycling systems is designed to reduce
pressure on natural resources and prevent hazardous substances from damaging the environment.
If you need information on these disposal systems, please contact your local waste administration.
The crossed-bin symbol invites you to use these disposal systems. If you require information on
collection and disposal of your ResMed device please contact your ResMed office, local distributor or
go to www.resmed.com/environment.
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Servicing
The Auto 25 device is intended to provide safe and reliable operation when operated in accordance
with the instructions provided by ResMed. ResMed recommends that the Auto 25 device be
inspected and serviced by an authorised ResMed Service Centre if there is any sign of wear or
concern with device function. Otherwise, service and inspection of the devices generally should not
be required during the five year design life of the device.
Limited warranty
ResMed Ltd (hereafter 'ResMed') warrants that your ResMed product shall be free from defects in
material and workmanship from the date of purchase for the period specified below.
Product
Warranty period
•
Mask systems (including mask frame, cushion, headgear and 90 days
tubing)—excluding single-use devices
•
Accessories—excluding single-use devices
•
Flex-type finger pulse sensors
•
Humidifier water tubs
•
Batteries for use in ResMed internal and external battery
6 months
systems
•
Clip-type finger pulse sensors
1 year
•
CPAP and bilevel device data modules
•
Oximeters and CPAP and bilevel device oximeter adapters
•
Humidifiers and humidifier cleanable water tubs
•
Titration control devices
•
CPAP, bilevel and ventilation devices (including external
2 years
power supply units)
•
Battery accessories
•
Portable diagnostic/screening devices
This warranty is only available to the initial consumer. It is not transferable.
If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the
defective product or any of its components.
This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse,
modification or alteration of the product; b) repairs carried out by any service organization that has not
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been expressly authorized by ResMed to perform such repairs; c) any damage or contamination due
to cigarette, pipe, cigar or other smoke; and d) any damage caused by water being spilled on or into
an electronic device.
Warranty is void on product sold, or resold, outside the region of original purchase.
Warranty claims on defective product must be made by the initial consumer at the point of purchase.
This warranty replaces all other expressed or implied warranties, including any implied warranty of
merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on
how long an implied warranty lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages claimed to have
resulted from the sale, installation or use of any ResMed product. Some regions or states do not
allow the exclusion or limitation of incidental or consequential damages, so the above limitation may
not apply to you.
This warranty gives you specific legal rights, and you may also have other rights which vary from
region to region. For further information on your warranty rights, contact your local ResMed dealer or
ResMed office.
WARNINGS
•
•
•
•
•
•
•
•
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Read the entire manual before using the device.
Use the device only as directed by your physician or healthcare provider.
Use the device only for the intended use as described in this manual. Advice contained in this
manual should not supersede instructions given by the prescribing physician.
If you notice any unexplained changes in the performance of the device, if it is making unusual
or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled
into the enclosure, or if the enclosure is broken, discontinue use and contact your ResMed
Service Center.
Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in
water. In the event of a spill, disconnect the device from the power supply and let the parts dry.
Always unplug the device before cleaning and make sure that all parts are dry before plugging in
the device.
Explosion hazard—do not use in the vicinity of flammable anesthetics.
Make sure the power cord and plug are in good condition and the equipment is not damaged.
Keep the power cord away from hot surfaces.
•
The device should only be used with masks (and connectors 1) recommended by ResMed, or by
a physician or respiratory therapist. A mask should not be used unless the device is turned on.
Once the mask is fitted, ensure that the device is blowing air. The vent hole or holes associated
with the mask should never be blocked.
Explanation: The device is 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
CPAP or bilevel devices.
•
•
•
•
•
•
•
•
•
1
Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an
open flame.
Always ensure that the device is turned on and airflow generated before the oxygen supply is
turned on. Always turn the oxygen supply off before the device is turned off, so that unused
oxygen does not accumulate within the device enclosure and create a risk of fire.
Do not leave long lengths of air tubing around the top of your bed. It could twist around your
head or neck while you are sleeping.
Do not use electrically conductive or antistatic air tubings.
Do not use the air tubing if there are any visible signs of damage.
Only ResMed air tubing and accessories should be used with the device. A different type of air
tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of
the treatment.
Only use the ResMed 90W or 30W power supply unit. Use the 90W power supply unit to power
the system comprising the device, H5i, air tubing, DC/DC converter and battery pack. The 30W
power supply unit is designed to power the device only and recommended for traveling.
Only ResMed products are designed to be connected to the module connector port. Connecting
other devices could damage the device.
Blocking the air tubing and/or air inlet of the device while in operation could lead to overheating
of the device.
Ports may be incorporated into the mask or in connectors that are near the mask.
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CAUTIONS
•
•
•
•
•
•
Do not open the device enclosure. There are no user serviceable parts inside. Repairs and
servicing should only be performed by an authorised ResMed service agent.
Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or antibacterial
soaps or scented oils to clean the device, humidifier or air tubing. These solutions may cause
damage and reduce the life of these products.
Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is
correctly set up.
Be careful not to place the device where it can be bumped or where someone is likely to trip
over the power cord.
Make sure the area around the device is dry and clean and clear of bedding, clothes or other
objects that could block the air inlet or cover the power supply unit.
Ensure that the device is protected against water if used outdoors. Enclose the device in the S9
travel bag for transport.
Manufacturer: ResMed 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.
For patent information, see www.resmed.com/ip.
S9, H5i, ClimateLine, SlimLine and SmartStart are trademarks of ResMed Ltd. S9, ClimateLine, SlimLine and SmartStart are registered in
U.S. Patent and Trademark Office.
© 2012 ResMed Ltd. 368696/2 2012-05
Global leaders in sleep and respiratory medicine
www.resmed.com
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