Resmed Autoset Cs-a User Manual

AutoSet™ CS-A
ADAPTIVE SERVO-VENTILATOR
Information Guide
English
Indications for use
The 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 (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnoea. 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
English 1
eye irritation
inserted too slowly.
positioned correctly.
EPAP may be set too low.
Talk to your clinician about your settings.
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
Fully insert the DC plug.
into the back of the device or
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
Check air tubing.
properly.
Air tubing is blocked, pinched or
Unblock or free the air tubing. Check the air tubing for punctures.
punctured.
Mask and headgear are not
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.
2
Device does not start when you breathe into the mask
Breath is not deep enough to
Take a deep breath in and out through the mask.
trigger SmartStart/Stop.
SmartStart/Stop is disabled
Press Start/Stop to start therapy. because the High Leak or Low Minute Ventilation alarm is enabled.
SmartStart/Stop is disabled
Press Start/Stop to start therapy. because Confirm Stop is enabled.
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
Press Start/Stop to stop therapy. because the High Leak or Low Minute Ventilation alarm is enabled.
SmartStart/Stop is disabled because Confirm Stop is
A message appears on the screen. To stop therapy, select Yes and
press the Push Dial. enabled.
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
Only use equipment recommended by ResMed. being used.
Incorrect mask setting being used.
The patient is using a nasal
Check the selected mask type in the Setup menu. Change it if
necessary.
Disable SmartStart/Stop. pillows mask with a set pressure less than 6 cm H
English 3
O.
2
Pressure rises inappropriately
reconnect it to restart the device.
of water in the air tubing.
inserted too slowly.
Talking, coughing or breathing in an unusual manner.
Mask cushion is buzzing against
Avoid talking with a nasal mask on, and breathe as normally as
possible.
Adjust the headgear. the skin.
Cushion seated incorrectly
Adjust headgear or re-fit cushion. causing excessive leak.
Displays message: High temperature fault, refer to user manual
Device has been left in a hot environment.
Air filter is blocked.
Allow to cool before re-use. Disconnect the power cord and then
reconnect it to restart the device.
Replace your air filter. Disconnect the power cord and then
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
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
Fully insert the DC plug. into the back of the device or
A non-ResMed power supply unit is connected to the device.
The power supply unit is being covered by bedding.
Remove the power supply unit and replace with a ResMed power
supply unit.
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.
4
displayed.
antibacterial filter is used.
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-
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
Remove your mask until power is restored.
Ensure the power cord is connected and the mains power switch
(if available) is on. off during therapy.
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.
Displays message: No tube, please check your tube is connected
Flow is high because air tubing
Connect the air tubing firmly at both ends. is not connected properly.
Note: The tube disconnection check may not operate when an
English 5
Problem/Possible cause Solution
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.
Oximeter sensor might be faulty.
Ensure that the oximeter sensor is attached properly to the module
and the patient's finger.
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
Talk to your clinician about your settings. supplemental oxygen may result in false triggering of this alarm on a vented mask.
Displays message: No oximeter, check/connect oximeter adapter
Oximeter adapter is not
Ensure that the oximeter adapter is attached properly. attached properly.
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.
6
Problem/Possible cause Solution
Power supply
90W power supply unit
30W power supply unit
90W DC/DC converter
Environmental
Operating temperature: +5°C to +35°C
Aircraft use
ResMed confirms that the device/s meets the Federal Aviation Administration
Displays message: Alarm module fault, please contact service provider
General failure of the device
Contact your service provider immediately. and/or the alarm module.
Therapy cannot be started again.
General technical specifications
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use Typical power consumption: 70W (80VA) Maximum power consumption: 110W (120VA)
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use Typical power consumption: 20W (40VA) Maximum power consumption: 36W (75VA)
Nominal inputs: 12V, 24V Typical power consumption: 70W Maximum power consumption: 110W
conditions
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
(FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.
English 7
Electromagnetic
compatibility
Product complies with all applicable electromagnetic compatibility requirements
IEC 60601-1
Class II (double insulation), Type BF, Ingress protection IP21
Mode pressure
CPAP mode
EPAP: 4–15 cm H2O; PS: 0–20 cm H2O
Maximum single
for > 6 sec; 40 cm H2O—if pressure exceeded for >1 sec
Physical
Nominal dimensions (L x W x H): 153 mm x 172 mm x 86 mm
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
Standard air filter: Polyester non-woven fiber
(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.
classification
AutoSet CS-A technical specifications
ranges
Set Pressure: 4–20 cm H2O ASV and ASVAuto mode
Maximum single fault steady state pressure: 30 cm H2O—if pressure exceeded
fault pressure
Weight: 1.04 kg Housing construction: Flame retardant engineering thermoplastic
carrier
8
Sound
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
tubing and H5i:
28 dBA with uncertainty of 2 dBA as measured according
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
tubing and H5i:
36 dBA with uncertainty of 2 dBA as measured according
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)
Air tubing
Material
Length
Inner diameter
ClimateLine heated air tubing
Flexible plastic and electrical components
2 m
15 mm
MAX
tubing
Flexible plastic and electrical
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
DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:1996
or Standard air
to EN ISO 17510-1:2009
or Standard air
to EN ISO 17510-1:2009
Air tubing technical specifications
ClimateLine
heated air
components
English 9
Notes:
Mask pressure
cm H2O
RH output %
Nominal system output AHa, BTPSb
Setting 3
Setting 6
Setting 3
Setting 6
3
90
100
10
18
10
95
100
11.5
21
20
95
100
11
18
25
100
100
12
13.5
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 H
O, the device optimum performance may not be
2
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 ClimateLine
MAX
is designed only for use with the H5i.
Humidifier performance
The following settings have been tested at 22°C ambient temperature:
a. AH - Absolute Humidity in mg/L. b. BTPS - Body Temperature Pressure Saturated.
Pneumatic flow path
1. Flow sensor
2. Blower
3. Pressure sensor
4. Mask
5. Air tubing
6. H5i
7. Alarm module
8. Device
9. Inlet filter
10
Pressure, cm H2O
AutoSet CS-A
L/min
AutoSet CS-A,
Standard, L/min
AutoSet CS-A
L/min
AutoSet CS-A, H5i
L/min
4
200
170
195
170 8 200
170
190
170
12
200
170
184
170
16
200
170
175
170
20
190
170
168
161
25
180
161
144
125
Pressure sensor at air outlet
Mask pressure
4–20 cm H2O (CPAP); 4–30 cm H2O (ASV, ASVAuto)
0.1 cm H2O Flow derived values
Leak
0–200 L/min
1 L/min
Tidal volume
0–4000 mL
1 mL
Respiratory rate
0–50 BPM
1 BPM
Minute ventilation
0–30 L/min
0.1 L/min
Flow (maximum) at set pressures
The following are measured at the end of the specified air tubing:
and Standard,
H5i and
and SlimLine,
Displayed values
Value Range Display resolution
English 11
and ClimateLine,
Pressure measurementa
Mask pressure
±0.5 cm H2O (+4% of measured value)
Flow measurementsa
Leakb
±12 L/min or 20% of reading, whichever is greater, at 0 to 60 L/min
Tidal volume
b.c
±20%
Respiratory rate
b, c
±1 BPM
Minute ventilation
b, c
±20%
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
Pressure (cm H2O)
10 BPM
15 BPM
20 BPM
AutoSet CS-A and Standard air tubing without H5i / AutoSet CS-A and
4
0.18 / 0.18
0.30 / 0.30
0.51 / 0.51
8
0.21 / 0.20
0.26 / 0.24
0.38 / 0.36
12
0.21 / 0.20
0.26 / 0.23
0.34 / 0.31
16
0.22 / 0.21
0.27 / 0.26
0.36 / 0.33
20
0.23 / 0.22
0.26 / 0.28
0.38 / 0.35
25
0.30 / 0.31
0.54 / 0.50
0.74 / 0.71
Value Accuracya
a. Results are expressed at ATPD (Ambient Temperature and Pressure, Dry). b. Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min. c. Measurement accuracy verified as per EN ISO 10651-6:2009 for Home Care Ventilatory Support Devices (Figure 101 and Table 101) using nominal ResMed mask vent flows.
Pressure accuracy
Maximum static pressure variation at 10 cm H2O according to EN ISO 17510-1:2009
Maximum dynamic pressure variation according to EN ISO 17510-1:2009
Standard air tubing with H5i
12
Pressure (cm H2O)
10 BPM
15 BPM
20 BPM
AutoSet CS-A and SlimLine air tubing without H5i / AutoSet CS-A and
SlimLine air tubing with H5i
4
0.22 / 0.20
0.28 / 0.29
0.47 / 0.53
8
0.23 / 0.19
0.32 / 0.29
0.41 / 0.42
12
0.22 / 0.21
0.35 / 0.29
0.41 / 0.45
16
0.22 / 0.23
0.41 / 0.33
0.44 / 0.50
20
0.24 / 0.27
0.37 / 0.34
0.48 / 0.50
25
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; Protection against insertion of fingers and against
vertically dripping water;
Manufacturer; European Authorised Representative; European RoHS; Batch
code;
Catalogue number; Serial number; Direct current; Lock/unlock;
China pollution control logo 1; China pollution control logo 2; Not drip proof; Keep
dry;
Alarm mute key;
Environmental information 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.
Type BF equipment; Class II equipment; Start/Stop;
English 13
Servicing
Mask systems (including mask frame, cushion, headgear and
Humidifier water tubs
90 days
Batteries for use in ResMed internal and external battery systems
6 months
Clip-type finger pulse sensors
Titration control devices
1 year
CPAP, bilevel and ventilation devices (including external
Portable diagnostic/screening devices
2 years
The AutoSet CS-A device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the AutoSet CS-A 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
tubing)—excluding single-use devices
Accessories—excluding single-use devices
Flex-type finger pulse sensors
CPAP and bilevel device data modules
Oximeters and CPAP and bilevel device oximeter adapters
Humidifiers and humidifier cleanable water tubs
power supply units)
Battery accessories
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 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
14
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
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.
1
Ports may be incorporated into the mask or in connectors that are near the mask.
English 15
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.
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 travelling.
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.
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, moisturizing 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.
16
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 that 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.
English 17
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.
ee www.resmed.com for other ResMed locations worldwide.
S
For patent information, see www.resmed.com/ip. S9, H5i, ClimateLine, SlimLine, SmartStart and AutoSet CS are trademarks of ResMed Ltd. S9, ClimateLine, SlimLine and SmartStart are registered in U.S. Patent and Trademark Office. © 2017 ResMed Ltd. 3681038/2 2017-11
Global leaders in sleep and respiratory medicine www.resmed.com
Loading...