ResMed S9 Elite Technical manual

1
S9 AutoSet™ & S9 Elite™
POSITIVE AIRWAY PRESSURE DEVICES
H5i™
HEATED HUMIDIFIER
ClimateLine™, SlimLine™ & Standard
AIR TUBING
Information Guide
English
S9 AutoSet indications for use
The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients
weighing more than 66 lb (>30 kg). The S9 AutoSet self-adjusting system is intended for home and hospital use.
S9 Elite indications for use
The S9 Elite CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more
than 66 lb (>30 kg). The S9 Elite CPAP system is intended for home and hospital use.
S9 contraindications
Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions:
•severe bullous lung disease
•pneumothorax
•pathologically low blood pressure
•dehydration
•cerebrospinal fluid leak, recent cranial surgery, or trauma.
S9 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 these devices:
•drying of the nose, mouth, or throat
•nosebleed
•bloating
•ear or sinus discomfort
•eye irritation
•skin rashes.
English
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H5i indications for use
The H5i is indicated for the humidification of the air delivered from a CPAP device. The H5i is for use only as
recommended by a physician. The H5i is intended for single patient re-use in the home environment and re-use in a
hospital/institutional environment.
H5i contraindications
The H5i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed.
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 these devices.
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 S9 and H5i are not connected correctly. Ensure that the S9 and H5i are securely attached.
Insufficient air delivered from the S9 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.
The H5i cover is not latched correctly. Make sure the cover is latched onto the docking station correctly.
The H5i cover seal is not fitted correctly. Make sure the cover seal is facing the right way up and fitted securely.
Incorrect air tubing selected. If you are using the SlimLine or Standard 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. Adjust position of mask and headgear.
Air tubing not connected properly. Connect firmly at both ends.
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not available if you are
using a Full Face Mask.
Enable SmartStart/Stop.
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.
Enable SmartStart/Stop.
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Problem/Possible Cause Solution
SmartStart/Stop is enabled but the CPAP 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 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.
Displays error message: Heated tube fault, replace tube
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.
There is a fault in your ClimateLine air tubing. Discontinue using your ClimateLine air tubing and contact your clinician/
service provider. Use Standard or SlimLine tubing in the interim.
Displays error message: Humidifier fault, replace humidifier
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.
There is a fault in your H5i heated humidifier. Discontinue using your H5i and contact your clinician/service provider.
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.
The device or air inlet is being covered by
bedding.
Make sure that the device is free from bedding, clothes or other objects
that could cover the device or block the air inlet. 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.
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 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.
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General technical specifications
Problem/Possible Cause Solution
Displays error message: Tube blocked, please check your tube
Air tubing is blocked. Check your air tubing and remove any blockages.
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 CPAP 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.
Water splashing on your face from the H5i
The water tub is overfilled. Check that the water level is below the maximum water level mark.
Condensation is forming in the air tube and mask. Turn the H5i or relative humidity setting down via the menu.
Leaking water tub
The water tub may be damaged or cracked. Contact your service provider for a replacement.
The cleanable water tub is not assembled
correctly.
Check for damage and reassemble the cleanable water tub correctly.
Air feels too warm/cold in the mask
The temperature of the ClimateLine air tubing is
set too high/low.
Turn up/down the heated tubing temperature via the menu.
90W power supply unit Input range 100–240V, 50–60Hz,
Nominal for aircraft use 110V, 400Hz
Typical power consumption 70W (80VA)
Maximum power consumption 110W (120VA)
30W power supply unit Input range 100–240V, 50–60Hz,
Nominal for aircraft use 110V, 400Hz
Typical power consumption 20W (30VA)
Maximum power consumption 36W (75VA)
Operating temperature 41ºF to 95ºF (+5ºC to +35ºC)
Operating humidity 10–95% non-condensing
Operating altitude Sea level to 8,500’ (2,591 m)
Storage and transport temperature -4ºF to 140ºF (-20ºC to +60ºC)
Storage and transport humidity 10–95% non-condensing
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S9 technical specifications
H5i technical specifications
Electromagnetic compatibility Product complies with all applicable electromagnetic compatibility
requirements (EMC) according to IEC60601-1-2, for residential,
commercial, and light industry environments. Information regarding the
electromagnetic emissions and immunity of these ResMed devices can
be found on www.resmed.com, on the Products page under Service
and Support. Click on the PDF file for your language.
Aircraft use ResMed confirms that the S9 AutoSet/Elite meets the Federal Aviation
Administration (FAA) requirements (RTCA/DO-160F) for all phases of air
travel.
IEC 60601-1 classification Class II (double insulation), Type BF
Operating pressure range 4 to 20 cm H2O
Maximum single fault steady state pressure 30 cm H2O
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
DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:
Sound pressure level 24 dBA as measured according to ISO 17510-1:2002
26 dBA with uncertainty of 2 dBA as measured according to
ISO 17510-1:2007
Sound power level 34 dBA with uncertainty of 2 dBA as measured according to
ISO 17510-1:2007
Nominal dimensions (L x W x H) 6.0” x 5.5” x 3.4” (153 mm x 140 mm x 86 mm)
Weight 1.8 lb (810 g)
Housing construction Flame retardant engineering thermoplastic
Supplemental oxygen Recommended maximum supplemental oxygen flow: 4 L/min
Hypoallergenic air filter Non-woven acrylic and polypropylene fibers with polypropylene carrier
Standard air filter Polyester fiber
Air outlet The 22 mm conical air outlet complies with ISO 5356-1
Maximum heater plate temperature 150°F (65°C)
Temperature cut-out 165°F (74°C)
Maximum gas temperature ≤106°F (≤41°C)
Nominal dimensions (L x W x H) Docking station and water tub: 6.0” x 5.7” x 3.4”
(153 mm x 145 mm x 86 mm)
Weight (water tub) Docking station and unfilled water tub 1.5 lb (0.67 kg)
Weight (cleanable water tub) Docking station and unfilled water tub 1.7 lb (0.77 kg)
Water capacity To maximum fill line 380 mL
Docking station Flame retardant engineering thermoplastic, aluminium
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Air tubing technical specifications
Notes:
•The manufacturer reserves the right to change these specifications without notice.
•The temperature and relative humidity settings displayed for ClimateLine are not measured values.
•Check with your clinician/service provider before using the SlimLine air tubing with devices other than the S9 or
H5i.
Humidifier performance
The following settings have been tested at 22°C, 40% RH ambient conditions:
Symbols which appear on these devices
The following symbols may appear on your S9, H5i, power supply unit, air tubing or packaging.
Caution; Read instructions before use; Follow instructions for use; Drip proof;
Not drip proof; Type BF equipment; Class II equipment; Start/Stop; Manufacturer;
European RoHS; Lot number; Part number; Serial number; Direct current;
Not for use on more than one patient; Maximum water level; Disinfectable up to 200°F (93°C);
Use distilled water only; Lock/unlock; Remove tub to fill; RxPrescription only
(In the US, Federal law restricts these devices to sale by or on the order of a physician.);
China pollution control logo 1; China pollution control logo 2.
Cleanable water tub Injection molded plastic, stainless steel and silicone seal
Water tub Injection molded plastic, aluminium and thermoplastic elastomer
ClimateLine air tubing Flexible plastic and electrical components,
6’5” (1.98 m), 15 mm inner diameter
SlimLine air tubing Flexible plastic, 6’ (1.83 m), 15 mm inner diameter
Standard air tubing Flexible plastic, 6’6” (2 m), 19 mm inner diameter
Heated tubing temperature cut-out ≤106°F (≤41°C)
CPAP mask pressure
cm H2O
RH output %
Setting 3 Setting 6
Nominal system output AHa, BTPSb
Setting 3 Setting 6
a. AH- Absolute Humidity in mg/L.
b. BTPS- Body Temperature Pressure Saturated.
41001002127
10 100 100 16 23
20 100 100 14 17
93 C
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Servicing
The S9 and H5i devices are intended to provide safe and reliable operation when operated in accordance with the
instructions provided by ResMed. ResMed recommends that the S9 and H5i be inspected and serviced by an authorized
ResMed Service Center 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.
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 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.
Product Warranty period
• Mask systems (including mask frame, cushion, headgear and tubing)—excluding single-use devices
• Accessories—excluding single-use devices
• Flex-type finger pulse sensors
• Humidifier water tubs
90 days
• Batteries for use in ResMed internal and external battery systems 6 months
• Clip-type finger pulse sensors
• CPAP and bilevel device data modules
• Oximeters and CPAP and bilevel device oximeter adapters
• Humidifiers and humidifier cleanable water tubs
• Titration control devices
1 year
• CPAP, bilevel and ventilation devices (including external power supply units)
• Battery accessories
• Portable diagnostic/screening devices
2 years
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GENERAL WARNINGS
•Read the entire manual before using these devices.
•In the US, Federal law restricts these devices to sale by or on the order of a physician.
•Use these devices only for their intended use as described in this manual.
•Do not open the S9 or H5i. There are no user serviceable parts inside. Repairs and servicing should only be
performed by an authorized ResMed service agent.
•Beware of electrocution. Do not immerse the S9 device, H5i docking station, power supply or power cord in water.
Always unplug these devices before cleaning and make sure they are dry before plugging them back in.
•Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils
to clean the S9, H5i or air tubing. These solutions may cause damage and reduce the life of these products.
•Follow all precautions when using supplemental oxygen.
•Explosion hazard—do not use in the vicinity of flammable anesthetics.
•Only use the ResMed 90W or 30W power supply units.
•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.
•Do not drop or insert any object into any tubing or opening.
•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.
S9 WARNINGS
•Advice contained in this manual should not supersede instructions given by the prescribing physician.
•Do not use your S9 if there are obvious external defects or unexplained changes in performance.
•Only ResMed air tubing and accessories should be used with these devices. A different type of air tubing or
accessory may alter the pressure you actually receive, reducing the effectiveness of your treatment.
•Blocking the air tubing and/or air inlet of the S9 device while in operation could lead to overheating of the device.
•If your clinician has told you to use the SD card to update the settings on your device and the “Settings updated
successfully” message does not appear, contact your clinician immediately.
•A patient should not connect a device to the module connector port unless instructed to do so by their health care
provider or physician. Only ResMed products are designed to be connected to the module connector port.
Connecting other devices could result in injury, or damage to the S9 device.
•These S9 devices should only be used with masks (and connectors1) 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: Your S9 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,
1. Ports may be incorporated into the mask or in connectors that are near the mask.
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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 devices.
•In the event of power failure1or machine malfunction, remove the mask.
•These S9 devices can be set to deliver pressures up to 20 cm H2O. In the unlikely event of certain fault conditions,
pressures up to 30 cm H2O are possible.
•Oxygen flow must be turned off when the CPAP device is not operating, so that unused oxygen does not
accumulate within the device enclosure and create a risk of fire.
•If the oxygen has been left on, turn off the device, then wait one hour before turning on the device again.
S9 CAUTIONS
•Be careful not to place your 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 or cover the power supply unit.
•Make sure the area around the device is dry and clean.
•Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack.
•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. Ensure the air filter and air filter
cover are fitted at all times.
•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 these devices 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).
H5i WARNINGS
•The H5i is designed only for use with specific ResMed devices. Do not use the H5i with any other CPAP device.
•Do not operate the H5i if it is not working properly or if any part of the CPAP device or H5i has been dropped or
damaged.
•The H5i should only be used with tubing or accessories recommended by ResMed. Connection of other delivery
tubes or accessories could result in injury, or damage to the device.
•Water must be prevented from entering your CPAP device.
•Do not overfill the water tub as water may enter the device and air tubing.
•Take care when handling your H5i as the water/water tub may be hot. Allow 10 minutes for the heater plate and any
excess water to cool.
•The H5i docking station should only be connected or disconnected when the water tub is empty.
•Make sure that the water tub is empty before transporting the H5i.
•Do not operate the H5i on an aircraft as water may enter the CPAP device and air tubing during turbulence.
•Always place the H5i on a level surface below the level of the user to prevent the mask and tubing from filling with
water.
•The H5i should be used with caution for users who are unable to remove the mask for themselves.
1. 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.
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•If liquids are inadvertently spilled into or on the H5i docking station, unplug the device from the power outlet.
Disconnect the docking station from the CPAP device and allow the docking station to drain and dry before re-
using.
AIR TUBING WARNINGS
•If damage to the air tubing results in air leaking, stop using the air tubing.
•Do not wash the air tubing in a washing machine or dishwasher.
•Avoid covering the ClimateLine air tubing with materials such as sheets or blankets.
•The ClimateLine is designed only for use with the H5i.
•ClimateLine is not compatible with supplemental oxygen.
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