ResMed H5i Technisches Handbuch

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

368515 S9 Series H5i Air tubing Information Guide AMER Multi.fm Page 1 Monday, July 4, 2011 3:17 PM

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

368515 S9 Series H5i Air tubing Information Guide AMER Multi.fm Page 10 Monday, July 4, 2011 3:17 PM

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