ResMed VPAP ST Technisches Handbuch

English 1

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VPAP™ST / VPAP™S

POSITIVE AIRWAY PRESSURE DEVICE

Information Guide

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English

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

VPAP ST indications for use

The S9 VPAP ST is intended to provide non-invasive ventilation to patients weighing more than 13 kg

with respiratory insufficiency or obstructive sleep apnoea (OSA). The S9 VPAP ST is intended for

home and hospital use.

VPAP S indications for use

The S9 VPAP S is intended to provide non-invasive ventilation to patients weighing more than 13 kg

with respiratory insufficiency or obstructive sleep apnoea (OSA). The S9 VPAP S is intended for home

and hospital use.

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.

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

into the back of the device or

inserted too slowly.

Fully insert the DC plug.

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

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.

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.

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.

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Problem/Possible cause Solution

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 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 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.

Mask cushion is buzzing against

the skin.

Adjust the headgear.

Cushion seated incorrectly

causing excessive leak.

Adjust headgear or re-fit cushion.

Displays 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.

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Problem/Possible cause Solution

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.

Humidity level setting is too

high, resulting in accumulation

of water in the air tubing.

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

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 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: High leak, please check system setup and all connections

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.

Connect the air tubing firmly at both ends.

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.

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Problem/Possible cause Solution

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-

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.

General technical specifications

Power supply 90W power supply unit

Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use

Typical power consumption: 70W (80VA)

Maximum power consumption: 110W (120VA)

30W power supply unit

Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use

Typical power consumption: 20W (40VA)

Maximum power consumption: 36W (75VA)

90W DC/DC converter

Nominal inputs: 12V, 24V

Typical power consumption: 70W

Maximum power consumption: 110W

Environmental

conditions

Operating temperature: +5°C to +35°C

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

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Aircraft use ResMed confirms that the device/s meets the Federal Aviation Administration

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

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.

IEC 60601-1

classification

Class II (double insulation), Type BF, Ingress protection IP21

Device technical specifications

Pressure and

flow state

Operating pressure range (measured at the mask): 4-20 cm H2O (CPAP), 2-

25 cm H2O (VPAP)

Maximum single fault steady state pressure: 30 cm H2O - if pressure exceeded

for > 6 sec; 40 cm H2O - if pressure exceeded for >1 sec

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

Mode reading CPAP mode

Set Pressure: 4 to 20 cm H2O

S, ST and T modes

IPAP: 4 to 25 cm H2O; EPAP: 2 to 25 cm H2O

Physical Nominal dimensions (L x W x H): 153 mm x 140 mm x 86 mm

Weight: 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

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Sound

DECLARED

DUAL-NUMBER

NOISE EMISSION

VALUES in

accordance with

ISO 4871:1996

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

or Standard air

tubing and H5i:

28 dBA with uncertainty of 2 dBA as measured according

to EN ISO 17510-1:2009

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

or Standard air

tubing and H5i:

36 dBA with uncertainty of 2 dBA as measured according

to EN ISO 17510-1:2009

Supplemental

oxygen

Recommended maximum supplemental oxygen flow: 15 L/min

Air tubing technical specifications

Air tubing Material Length Inner diameter

ClimateLine heated air tubing Flexible plastic and electrical

components

2 m 15 mm

ClimateLineMAX heated air

tubing

Flexible plastic and electrical

components

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

Notes:

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.

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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 H2O, the device optimum performance

may not be 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 ClimateLineMAX is designed only for use with the H5i.

Humidifier performance

The following settings have been tested at 22°C ambient temperature:

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.

Pneumatic flow path

1. Inlet filter

2. Blower

3. Air tubing

4. Mask

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Flow (maximum) at set pressures

The following are measured at the end of the specified air tubing:

Pressure, cm H2O VPAP and

Standard, L/min

VPAP, H5i and

Standard, L/min

VPAP and

SlimLine, L/min

VPAP, H5i and

ClimateLine,

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

Displayed values

Value Range Accuracy Display resolution

Pressure sensor at air outlet

Pressure 2 to 25 cm H2O ±0.5 cm H2O (±4% of

measured value)

0.1 cm H2O

Flow derived valuesa

Leak 0

–

200 L/min b1 L/min

Tidal volume 0

–

4000 mL ±10% 1 mL

Respiratory rate 0

–

50 BPM ±1 BPM c1 BPM

Minute ventilation 0

–

30 L/min ±10% 0.1 L/min

Ti Avg 0

–

4.0 sec ±10% 0.2 sec

a. Results may be inaccurate in the presence of leaks or supplemental oxygen.

b. The displayed values are estimates. They are provided for trending purposes only.

c. Results may be inaccurate if the tidal volume is below 50 mL.

Pressure accuracy

Maximum static pressure variation at 10 cm H2O according to EN ISO 17510-1:2009

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

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Maximum dynamic pressure variation according to EN ISO 17510-1:2009

Pressure (cm H2O) 10 BPM 15 BPM 20 BPM

VPAP and Standard air tubing without H5i / VPAP and Standard air tubing

with H5i

40.18 / 0.18 0.30 / 0.30 0.51 / 0.51

80.21 / 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

Pressure (cm H2O) 10 BPM 15 BPM 20 BPM

VPAP and SlimLine air tubing without H5i / VPAP and SlimLine air tubing

with H5i

40.22 / 0.20 0.28 / 0.29 0.47 / 0.53

80.23 / 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; Type BF equipment; Class II equipment; Start/Stop;

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;

Andere Handbücher für VPAP ST

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