ResMed S9 AutoSet CS-A Technical manual

AutoSet™CS-A
ADAPTIVE SERVO-VENTILATOR
Information Guide
English
Please read the entire Information and Welcome Guides before using your device.
Indications for use
The S9 AutoSet CS-A is indicated to stabilise the ventilation of adult patients exhibiting central
sleep apnoea (CSA), mixed sleep apnoea and periodic breathing, with or without obstructive
sleep apnoea. It is intended for home and hospital use.
Contraindications
ASV therapy is contraindicated in patients with chronic, symptomatic heart failure with reduced
left ventricular ejection fraction (LVEF ≤ 45%).
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
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•eye irritation
•skin rashes.
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 cord 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 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 3 m air tubing ensure
that you have the correct air tubing selected via the menu.
Non-vented mask is used. Only use a vented mask.
Mask vents might be blocked. Check if you have sufficient venting. Unblock mask vents if
necessary.
EPAP may be set too low. Talk to your clinician about your settings.
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Problem/Possible cause Solution
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.
SmartStart/Stop is disabled
because the High Leak or Low
Minute Ventilation alarm is
enabled.
Press Start/Stop to start therapy.
SmartStart/Stop is disabled. Talk to your clinician about enabling the SmartStart/Stop feature.
There is excessive leak. Adjust position of mask and headgear.
Connect the air tubing firmly at both ends.
Device does not stop when you remove your mask
SmartStart/Stop is disabled
because the High Leak or Low
Minute Ventilation alarm is
enabled.
Press Start/Stop to stop therapy.
SmartStart/Stop is disabled
because Confirm Stop is
enabled.
A message appears on the screen. To stop therapy, select Yes and
press the Push Dial.
SmartStart/Stop is disabled. Talk to your clinician about enabling the SmartStart/Stop feature.
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.
Incorrect mask setting being
used.
Check the selected mask type in the Setup menu. Change it if
necessary.
The patient is using a nasal
pillows mask with a set
pressure less than 6 cm H2O.
Disable SmartStart/Stop.
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Problem/Possible cause Solution
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.
Displays 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.
Humidity level setting is too
high, resulting in accumulation
of water in the air tubing.
Turn the humidity level setting down and empty the water from
the air tubing.
Displays 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.
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.
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Problem/Possible cause Solution
You may have removed the
SD card before settings were
copied to the device.
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 re-
displayed.
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.
Alarms
If the system has not been properly assembled, the device will trigger an alarm. Check that the air
tubing has been properly attached to the device and mask (and humidifier if used).
Problem/Possible cause Solution
Alarm is activated and the LCD screen display disappears
Power failure.
Power cord is disconnected or
mains power switch is turned
off during therapy.
Remove your mask until power is restored.
Ensure the power cord is connected and the mains power switch
(if available) is on.
Displays message: High leak, please check system setup and all connections
There is excessive leak. Adjust position of mask and headgear.
Connect the air tubing firmly at both ends.
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Problem/Possible cause Solution
Displays message: No tube, please check your tube is connected
Flow is high because air tubing
is not connected properly.
Note: The tube disconnection
check may not operate when an
antibacterial filter is used.
Connect the air tubing firmly at both ends.
Displays 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 message: No SpO2 data, check oxi sensor attachment to module/finger
Oximeter sensor is not attached
properly.
Ensure that the oximeter sensor is attached properly to the module
and the patient's finger.
Oximeter sensor might be
faulty.
If the message appears repeatedly but the oximeter is attached
properly to the module and the patient's finger, the oximeter
sensor might be faulty.
Contact your service provider or exchange the oximeter.
Displays message: Non-vented mask, use vented mask or unblock mask vents
Non-vented mask is used. Only use a vented mask.
Mask vents might be blocked. Check if you have sufficient venting. Unblock mask vents if
necessary.
A low EPAP in conjunction with
supplemental oxygen may result
in false triggering of this alarm
on a vented mask.
Talk to your clinician about your settings.
Displays message: No oximeter, check/connect oximeter adapter
Oximeter adapter is not
attached properly.
Ensure that the oximeter adapter is attached properly.
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Problem/Possible cause Solution
Oximeter adapter might be
faulty.
If the message appears repeatedly but the oximeter adapter is
attached properly, the oximeter adapter might be faulty.
Contact your service provider.
Displays message: Check ResMed 30/90W Power Supply Unit
The power supply unit is being
covered by bedding.
The power supply unit is
overheated.
Make sure that the power supply unit is free from bedding, clothes
or other objects that could cover it.
Let the power supply unit cool down.
The DC plug is partially inserted
into the back of the device or
inserted too slowly.
Fully insert the DC plug.
Displays message: Alarm module fault, please contact service provider
General failure of the device
and/or the alarm module.
Therapy cannot be started again.
Contact your service provider immediately.
General technical specifications
Power supply
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
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Environmental
conditions
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 2,591 m; air pressure range 1013 hPa to 738 hPa
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: 10 to 95% non-condensing
Aircraft use
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.
Electromagnetic
compatibility
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.
IEC 60601-1
classification
Class II (double insulation), Type BF, Ingress protection IP21
AutoSet CS-A technical specifications
Mode pressure
ranges
CPAP mode
Set Pressure: 4–20 cm H2O
ASV and ASVAuto mode
EPAP: 4–15 cm H2O; PS: 0–20 cm H2O
Maximum single
fault pressure
Maximum single fault steady state pressure: 30 cm H
2
O—if pressure exceeded
for > 6 sec; 40 cm H2O—if pressure exceeded for >1 sec
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Physical
Nominal dimensions (L x W x H): 153 mm x 172 mm x 86 mm
Weight: 1.04 kg
Housing construction: Flame retardant engineering thermoplastic
Air outlet: 22 mm conical air outlet (complies with ISO 5356-1:2004)
Air filter
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
Pressure level (CPAP mode)
With SlimLine air
tubing:
26 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
With Standard air
tubing:
27 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
With either SlimLine
or Standard air
tubing and H5i:
28 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
Power level (CPAP mode)
With SlimLine air
tubing:
34 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
With Standard air
tubing:
35 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
With either SlimLine
or Standard air
tubing and H5i:
36 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
Alarm volume
settings
Low (nominal 56 dBA), Medium (nominal 68 dBA), High (nominal 80 dBA)
Supplemental
oxygen
Recommended maximum supplemental oxygen flow:
15 L/min (CPAP, ASV modes); 4 L/min (ASVAuto mode)
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Air tubing technical specifications
Air tubing
Material
Length
Inner diameter
ClimateLine heated air tubing
Flexible plastic and electrical
components
2 m
15 mm
ClimateLine
MAX
heated air
tubing
Flexible plastic and electrical
components
1.9 m
19 mm
SlimLine air tubing
Flexible plastic
1.8 m
15 mm
Standard air tubing
Flexible plastic
2 m
19 mm
3 m air tubing
Flexible plastic
3 m
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.
•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.
•When using the SlimLine or ClimateLine above 20 cm H2O, the device optimum performance
may not be reached if used with an antibacterial filter. The device performance must be checked
prior to prescribing the SlimLine for use with an antibacterial filter.
•The ClimateLine or ClimateLineMAX is designed only for use with the H5i.
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