ResMed H5i Technical manual

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S9 AutoSet™ / S9 AutoSet™ for Her / S9 Elite™ / S9 Escape™ / S9 Escape Auto™
POSITIVE AIRWAY PRESSURE DEVICES
H5i™ / H5i™ for Her
HEATED HUMIDIFIER
ClimateLine™/ ClimateLineMAX™ / SlimLine™/ Standard
AIR TUBING
Information Guide
English • Français • Español • Português
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 AutoSet for Her indications for use
The S9 AutoSet for Her 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 for Her 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 Escape Auto indications for use
The S9 Escape Auto self-adjusting system is indicated for the treatment of obstructive sleep apnea
(OSA) in patients weighing more than 66 lb (>30 kg). The S9 Escape Auto self-adjusting system is
intended for home and hospital use.
S9 Escape indications for use
The S9 Escape CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients
weighing more than 66 lb (>30 kg). The S9 Escape CPAP system is intended for home and hospital use.
English
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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.
H5i indications for use
The H5i is indicated for the humidification of the air delivered from a CPAP or bilevel 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 for Her indications for use
The H5i for Her is indicated for the humidification of the air delivered from a CPAP or bilevel device. The
H5i is for use only as recommended by a physician. The H5i for Her 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.
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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 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 DC plug is partially inserted into the
back of the device.
Fully insert the DC plug.
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 flip lid is not latched correctly. Close the flip lid ensuring that it clicks into place.
The H5i flip lid seal is not fitted correctly. Make sure the flip lid 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.
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SmartStart/Stop is disabled.
Note: SmartStart/Stop is not available in
S9 Escape and S9 Escape Auto.
Enable SmartStart/Stop.
Device does not stop when you remove your mask
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not available in
S9 Escape and S9 Escape Auto.
Enable SmartStart/Stop.
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
7cmH
2O.
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 or
ClimateLineMAX air tubing.
Discontinue using your ClimateLine or ClimateLineMAX 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.
Problem/possible cause Solution
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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.
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.
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 H5i flip lid is not latched correctly. Close the flip lid ensuring that it clicks into place.
Displays error message: Please close H5i flip lid, attach tube and press any key
H5i flip lid is not closed. Close the flip lid ensuring that it clicks into place.
Air tubing is not connected properly. Connect firmly at both ends.
Problem/possible cause Solution
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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 or
ClimateLineMAX air tubing is set too
high/low.
Turn up/down the heated tubing temperature via the menu.
Problem/possible cause Solution
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General technical specifications
S9 technical specifications
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
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 Series 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
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H5i technical specifications
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 (835 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
Cleanable water tub Injection molded plastic, stainless steel and silicone seal
Water tub Injection molded plastic, aluminium and thermoplastic
elastomer
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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 or ClimateLineMAX 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 ambient temperature:
Symbols
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 Authorised Representative; European RoHS;
ClimateLine heated air tubing Flexible plastic and electrical components,
6’6” (2 m), 15 mm inner diameter
ClimateLineMAX heated air tubing Flexible plastic and electrical components,
6’3” (1.9 m), 19 mm inner diameter
SlimLine air tubing Flexible plastic, 6’ (1.8 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 % Nominal system output AHa, BTPSb
a. AH - Absolute Humidity in mg/L.
b. BTPS - Body Temperature Pressure Saturated.
Setting 3 Setting 6 Setting 3 Setting 6
4901001018
10 95 100 11.5 21
20 95 100 11 18
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Batch code; Catalogue 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 or deionized water only; Lock/unlock;
Remove tub to fill; Rx Only Prescription 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.
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.
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
• 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
• Humidifiers
2 years
93 C
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