ResMed S9 Series Technisches Handbuch

English

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VPAP Auto™/ VPAP™ST / VPAP™S

POSITIVE AIRWAY PRESSURE DEVICE

H5i™

HEATED HUMIDIFIER

ClimateLine™/ SlimLine™/ Standard

AIR TUBING

Information Guide

English • Français • Español • Português

English

Please read the entire Information and Welcome Guides before using your device.

S9 indications for use

The S9 VPAP Auto, S9 VPAP ST and S9 VPAP S are indicated for the treatment of obstructive sleep

apnea (OSA) in patients weighing more than 66 lb (30 kg). These devices are 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 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

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•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 an S9 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 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 the device(s).

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.

English

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Problem/possible cause Solution

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, Standard or 3m 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.

Note: If Leak Alert is enabled, an

audible alert is activated and a high leak

message is displayed.

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 or if

Leak Alert is enabled.

Enable SmartStart/Stop.

Device does not stop when you remove your mask

SmartStart/Stop is disabled.

Note: SmartStart/Stop is not available if

you are using a Full Face Mask or if

Leak Alert is enabled.

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 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.

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Problem/possible cause Solution

Mask cushion is buzzing against the

skin.

Adjust the headgear.

Cushion seated incorrectly causing

excessive leak. Adjust headgear or re-fit cushion.

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 SlimLine, Standard or

3m air 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.

Air filter is blocked. Replace your air filter. Discconect 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.

English

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Problem/possible cause Solution

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.

Disconnect the power cord and then reconnect it to restart

the device.

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 S9

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.

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Problem/possible cause Solution

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.

General technical specifications

Power supply

unit

90W Input range: 100-240V, 50-60Hz, 110V, 400Hz nominal for aircraft use

Typical power consumption: 70W (80VA)

Maximum power consumption: 110W (120VA)

30W Input range: 100-240V, 50-60Hz, 110V, 400Hz nominal for aircraft use

Typical power consumption: 20W (30VA)

Maximum power consumption: 36W (75VA)

Environmental

conditions

Operating temperature: 41°F to 95°F (+5°C to +35°C)

Operating humidity: 10-95% non-condensing

Operating altitude: Sea level to 8,500’ (2,591m)

Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)

Storage and transport humidity: 10-95% non-condensing

Aircraft use ResMed confirms that this device meets the Federal Aviation Administration

(FAA) requirements (RTCA/DO-160F, 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. 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

S9 technical specifications

Pressure and

flow state

Operating pressure range: 3 to 25 cm H2O

Maximum single fault steady state pressure: 40 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,

at 0 to 150 L/min positive flow

English

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Mode reading CPAP mode

Set Pressure: 4 to 20 cm H2O

S, ST and T modes

IPAP: 4 to 25 cm H2O; EPAP: 3 to 25 cm H2O

VAuto mode

Min EPAP: 4 cm H2O; Max IPAP: 25 cm H2O; Pressure support: 0 to 10 cm H2O

Physical Nominal dimensions (L x W x H): 6.0" x 5.5" x 3.4" (153 mm x 140 mm x 86 mm)

Weight: 1.84 lb (835 g)

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 tube: 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

With Standard tube: 24 dBA as measured according to ISO 17510-1:2002

27 dBA with uncertainty of 2 dBA as measured according

to ISO 17510-1:2007

With either SlimLine

or Standard tube and

H5i:

27 dBA as measured according to ISO 17510-1:2002

28 dBA with uncertainty of 2 dBA as measured according

to ISO 17510-1:2007

Power level (CPAP mode)

With SlimLine tube: 34 dBA with uncertainty of 2 dBA as measured according

to ISO 17510-1:2007

With Standard tube: 35 dBA with uncertainty of 2 dBA as measured according

to ISO 17510-1:2007

With either SlimLine

or Standard tube and

H5i:

36 dBA with uncertainty of 2 dBA as measured according

to ISO 17510-1:2007

Supplemental

oxygen

Recommended maximum supplemental oxygen flow: 4 L/min (VAuto mode);

15 L/min (S, ST and T modes)

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H5i technical specifications

Temperature Maximum heater plate temperature: 150°F (65°C)

Temperature cut-out: 165°F (74°C)

Maximum gas temperature: ≤106°F (≤41°C)

Physical Dimensions (L x W x H): 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 (670 g)

Weight (cleanable water tub): Docking station and unfilled water tub 1.7 lb

(770 g)

Water capacity: To maximum fill line 380 mL

Materials 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

Air tubing technical specifications

Maximum

recommended

pressure

Air tubing Material Length Inner diameter

20 cm H2O ClimateLine heated air

tubing

Flexible plastic and

electrical

components

6’6” (2 m) 0.6” (15 mm)

SlimLine air tubing Flexible plastic 6’ (1.8 m) 0.6” (15 mm)

25 cm H2O Standard air tubing Flexible plastic 6’6” (2 m) 0.75” (19 mm)

3m air tubing Flexible plastic 9’10” (3 m) 0.6” (15 mm)

Heated tubing temperature cut-out: ≤106°F (≤41°C).

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.

English

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Humidifier performance

The following settings have been tested at 22°C, 40% RH ambient conditions:

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

a. AH - Absolute Humidity in mg/L.

b. BTPS - Body Temperature Pressure Saturated.

Symbols

The following symbols may appear on your product 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 or deionized water only; Lock/unlock;

Remove tub to fill; RxOnly 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.

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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

•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

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

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