ResMed VPAP™ ST-A + iVAPS / VPAP™ ST-A

NONINVASIVE VENTILATOR

Information Guide

English

Please read the entire Information and Welcome Guides before using the VPAP ST-A or VPAP ST-A + iVAPS (hereafter 'VPAP ST-A').

Note: The iVAPS mode is not available in all devices.

Asia Pacific

VPAP ST-A indications for use

The VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 13 kg or more than 30 kg in iVAPS mode with respiratory insufficiency or obstructive sleep apnoea (OSA). The VPAP ST-A is intended for home and hospital use.

The Nordic countries and the UK

VPAP ST-A + iVAPS indications for use

The VPAP ST-A + iVAPS is indicated to provide noninvasive ventilation for patients weighing more than 13 kg or more than 30 kg in iVAPS mode with respiratory insufficiency or obstructive sleep apnoea (OSA). The VPAP ST-A + iVAPS is intended for home and hospital use.

VPAP ST-A indications for use

The VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 13 kg with respiratory insufficiency or obstructive sleep apnoea (OSA). The VPAP ST-A is intended for home and hospital use.

Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions:

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:

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.
The DC plug is partially inserted into the back of the device or inserted too slowly.
Ensure the power cord is connected and the power outlet (if available) is on.
Fully insert the DC plug.
Insufficient air delivered from the device
Ramp time is in use.
Air filter is dirty.
Air tubing is not connected properly.
Air tubing is blocked, pinched or punctured.
Mask and headgear are not positioned correctly.
Wait for air pressure to build up or change ramp time.
Replace air filter.
Check air tubing.
Unblock or free the air tubing. Check the air tubing for punctures.
Adjust position of mask and headgear.
Device issues related to tubing, mask, or settings
Incorrect air tubing selected.
Non-vented mask is used.
Mask vents might be blocked.
EPAP may be set too low.
If you are using the SlimLine, Standard or 3 m air tubing ensure that you have the correct air tubing selected via the menu.
Only use a vented mask.
Check if you have sufficient venting. Unblock mask vents if necessary.
Talk to your clinician about your settings.
Device does not start when you breathe into the mask
Breath is not deep enough to trigger SmartStart/Stop.
SmartStart/Stop is disabled because the High Leak or Low Minute Ventilation alarm is enabled.
SmartStart/Stop is disabled.
Take a deep breath in and out through the mask.
Press Start/Stop to start therapy.
Talk to your clinician about enabling the SmartStart/Stop feature.
There is excessive leak. Adjust position of mask and headgear.
Connect the air tubing firmly at both ends.
Device does not stop when you remove your mask
SmartStart/Stop is disabled because the High Leak or Low Minute Ventilation alarm is enabled.
SmartStart/Stop is disabled because Confirm Stop is enabled.
SmartStart/Stop is disabled.
Press Start/Stop to stop therapy.
A message appears on the screen. To stop therapy, select Yes and press the Push Dial.
Talk to your clinician about enabling the SmartStart/Stop feature.
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.
Incorrect mask settings or pressure issues
Incorrect mask setting being used.
The patient is using a nasal pillows mask with a set pressure less than 6 cm H2O.
The patient is using a paediatric mask with a set pressure less than 8 cm H2O.
Check the selected mask type in the Setup menu. Change it if necessary.
Disable SmartStart/Stop.
Disable SmartStart/Stop.
Pressure rises inappropriately
Talking, coughing or breathing in an unusual manner.
Mask cushion is buzzing against the skin.
Cushion seated incorrectly causing excessive leak.
Avoid talking with a nasal mask on, and breathe as normally as possible.
Adjust the headgear.
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.
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.
Power supply unit issues
A non-ResMed power supply unit is connected to the device.
The power supply unit is being covered by bedding.
Remove the power supply unit and replace with a ResMed power supply unit.
Make sure that the power supply unit is free from bedding, clothes or other objects that could cover it.
SD card issues
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.
You may have removed the SD card before settings were copied to the device.
Ensure that the SD card is inserted correctly.
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.
Settings update failure
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.
Alarms
If the system has not been properly assembled, the device will trigger an alarm. Check that the air tubing has been properly attached to the device and mask (and humidifier if used).  
Alarm is activated and the LCD screen display disappears
Power failure.
Power cord is disconnected or mains power switch is turned off during therapy.
Remove your mask until power is restored.
Ensure the power cord is connected and the mains power switch (if available) is on.
Displays message: High leak, please check system setup and all connections
There is excessive leak. Adjust position of mask and headgear.
Connect the air tubing firmly at both ends.
Displays message: No tube, please check your tube is connected
Flow is high because air tubing is not connected properly.
Note: The tube disconnection check may not operate when an antibacterial filter is used.
Connect the air tubing firmly at both ends.
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: No SpO2 data, check oxi sensor attachment to module/finger
Oximeter sensor is not attached properly.
Oximeter sensor might be faulty.
Ensure that the oximeter sensor is attached properly to the module and the patient's finger.
If the message appears repeatedly but the oximeter is attached properly to the module and the patient's finger, the oximeter sensor might be faulty.
Contact your service provider or exchange the oximeter.
Displays message: Non-vented mask, use vented mask or unblock mask vents
Non-vented mask is used.
Mask vents might be blocked.
A low EPAP in conjunction with supplemental oxygen may result in false triggering of this alarm on a vented mask.
Only use a vented mask.
Check if you have sufficient venting. Unblock mask vents if necessary.
Talk to your clinician about your settings.
Displays message: No oximeter, check/connect oximeter adapter
Oximeter adapter is not attached properly.
Oximeter adapter might be faulty.
Ensure that the oximeter adapter is attached properly.
If the message appears repeatedly but the oximeter adapter is attached properly, the oximeter adapter might be faulty.
Contact your service provider.
Displays message: Check ResMed 30/90W Power Supply Unit
The power supply unit is being covered by bedding.
The power supply unit is overheated.
The DC plug is partially inserted into the back of the device or inserted too slowly.
Make sure that the power supply unit is free from bedding, clothes or other objects that could cover it.
Let the power supply unit cool down.
Fully insert the DC plug.
Displays message: Alarm module fault, please contact service provider
General failure of the device and/or the alarm module.
Therapy cannot be started again.
Contact your service provider immediately.

General Technical Specifications

Power supply

Specification Details
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 (40°C) 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

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

VPAP ST-A Technical Specifications

Mode pressure ranges

Mode Specification
CPAP mode Set Pressure: 4–20 cm H2O
S, ST, T and PAC modes IPAP: 4–30 cm H2O; EPAP: 2–25 cm H2O
iVAPS mode PS: 0–28 cm H2O; EPAP: 2–25 cm H2O

Maximum single fault pressure

Maximum single fault steady state pressure: 30 cm H2O—if pressure exceeded for > 6 sec; 40 cm H2O—if pressure exceeded for >1 sec

Physical

Nominal dimensions (L x W x H): 153 mm x 172 mm x 86 mm
Weight: 1.04 kg
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)

Tubing Type Sound Level
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)

Tubing Type Sound Level
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

Alarm volume settings

Low (nominal 56 dBA), Medium (nominal 68 dBA), High (nominal 80 dBA)

Supplemental oxygen

Recommended maximum supplemental oxygen flow: 15 L/min (CPAP, S, ST, T, PAC); 4 L/min (iVAPS mode)

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:

Humidifier performance

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

Mask pressure
cm H2O
RH output %
Setting 3
RH output %
Setting 6
Nominal system output AHª, BTPSb
Setting 3
Nominal system output AHª, BTPSb
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

Diagram showing the pneumatic flow path with numbered components: 1. Flow sensor, 2. Blower, 3. Pressure sensor, 4. Mask, 5. Air tubing, 6. H5i, 7. Alarm module, 8. Device, 9. Inlet filter.

Flow (maximum) at set pressures

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

Pressure, cm H2O VPAP ST-A and Standard, L/min VPAP ST-A, H5i and Standard, L/min VPAP ST-A and SlimLine, L/min VPAP ST-A, 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

Pressure sensor at air outlet

Value Range Display resolution
Mask pressure 2–30 cm H2O 0.1 cm H2O

Flow derived values

Value Range Display resolution
Leak 0–200 L/min 1 L/min
Tidal volume 0–4000 mL 1 mL
Respiratory rate 0–50 BPM 1 BPM
Minute ventilation 0–30 L/min 0.1 L/min
Ti 0.1–4.0 sec 0.1 sec
I:E ratio 1:50–2:1 0.1

Pressure measurement

Value Accuracy
Mask pressure ±0.5 cm H2O (+4% of measured value)

Flow measurements

Value Accuracy
Leak ±12 L/min or 20% of reading, whichever is greater, at 0 to 60 L/min
Tidal volume ±20%
Respiratory rate ±1 BPM
Minute ventilation ±20%

a. Results are expressed at ATPD (Ambient Temperature and Pressure, Dry).
b. Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min.
c. Measurement accuracy verified as per EN ISO 10651-6:2009 for Home Care Ventilatory Support Devices (Figure 101 and Table 101).

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

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

Pressure (cm H2O) 10 BPM 15 BPM 20 BPM
VPAP ST-A and Standard air tubing without H5i / VPAP ST-A and Standard air tubing with H5i
4 0.18/0.18 0.30/0.30 0.51/0.51
8 0.21 / 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
VPAP ST-A and SlimLine air tubing without H5i / VPAP ST-A and SlimLine air tubing with H5i
4 0.22/0.20 0.28/0.29 0.47/0.53
8 0.23 / 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.

Environmental information

WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. This device should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment.

If you need information on these disposal systems, please contact your local waste administration.

The ♻️ symbol invites you to use these disposal systems. If you require information on collection and disposal of your ResMed device please contact your ResMed office, local distributor or go to www.resmed.com/environment.

Servicing

The VPAP ST-A device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the VPAP ST-A device be inspected and serviced by an authorised ResMed Service Centre 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 Pty 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 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.

WARNINGS

¹ Ports may be incorporated into the mask or in connectors that are near the mask.

Explanation

The device 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, 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 or bilevel devices.

CAUTIONS

Manufacturer: ResMed Pty Ltd 1Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.

See www.resmed.com for other ResMed locations worldwide.

For patent information, see www.resmed.com/ip.

S9, H5i, ClimateLine, SlimLine, SmartStart and VPAP are trademarks of ResMed. S9, ClimateLine, SlimLine, SmartStart and VPAP are registered in U.S. Patent and Trademark Office.

© 2017 ResMed. 368823/2 2017-12

Global leaders in sleep and respiratory medicine www.resmed.com

CE 0123

Models: VPAP ST-A iVAPS, VPAP ST-A, S9 VPAP ST-A, Non-Invasive Ventilation

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