ResMed S9 VPAP Tx User Manual

S9 VPAP™ Tx

POSITIVE AIRWAY PRESSURE THERAPY DEVICE

Clinical Guide

English

S9 VPAP™ Tx

POSITIVE AIRWAY PRESSURE THERAPY DEVICE

Clinical Guide

English

Contents
General warnings and cautions..............................................................	1
Welcome ...............................................................................................	2
S9 VPAP Tx indications for use........................................................	2
S9 VPAP Tx contraindications..........................................................	2
S9 VPAP Tx adverse effects............................................................	2
S9 VPAP Tx at a glance...........................................................................	3
Masks.............................................................................................	4
Supplemental oxygen.....................................................................	4
Antibacterial filters .........................................................................	4
Humidifier.......................................................................................	4
USB Adapter...................................................................................	4
Climate Control...............................................................................	4
Therapy modes.......................................................................................	5
S9 VPAP Tx basics..................................................................................	6
Setting up the S9 VPAP Tx......................................................................	7
Mask and air tubing settings..........................................................	10
Navigating the menus............................................................................	11
About the menus...................................................................................	11
Home menu...................................................................................	11
Setup menu...................................................................................	15
Info menu.......................................................................................	19
Managing Climate Control.............................................................	20
Delivering therapy..................................................................................	21
Adding supplemental oxygen.........................................................	22
Cleaning and maintenance....................................................................	23
Reprocessing the H5i and air tubing between patients.................	23
Replacing the air filter....................................................................	23
Working with alarms..............................................................................	24
Alarms menu.................................................................................	24
Testing the alarms..........................................................................	24
Troubleshooting.....................................................................................	25
Technical specifications.........................................................................	27
General technical specifications.....................................................	27
S9 VPAP Tx technical specifications...............................................	27
Pneumatic flow path......................................................................	28
Flow (maximum) at set pressures.................................................	29
Displayed values............................................................................	29
Symbols.........................................................................................	30
Servicing................................................................................................	30
Limited warranty....................................................................................	31

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General warnings and cautions

WARNINGS

•• Read the entire manual before using the device.

•• Use the device only as directed by the physician or healthcare provider.

•• Use the device only for the intended use as described in this manual. Advice contained in this manual should not supersede instructions given by the physician.

•• If you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your ResMed Service Center.

•• The device should only be used with masks (and connectors) recommended by ResMed or by a physician or respiratory therapist. A mask should not be used unless the device is turned on. Once the mask is fitted, ensure that the device is blowing air.The vent hole or holes associated with the mask should never be blocked.

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

•• Only ResMed air tubing and accessories should be used with the device. A different type of air tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of the treatment.

•• Only use the ResMed 90W or 30W power supply unit. Use the 90W power supply unit to power the system comprising the device, H5i, air tubing, DC/DC converter and battery pack.The 30W power supply unit is designed to power the device only and recommended for traveling.

•• To maintain electrical safety and in accordance with IEC 60601, where a personal computer is used with the flow generator, the personal computer must be at least 5’ (1.5 m) away from, or at least 8’ (2.5 m) above the patient.The Personal Computer must comply to IEC 60950.

CAUTIONS

•• In the US, Federal law restricts the device to sale by or on order of a physician.

•• Ensure that the device is protected against water. Enclose the device in the S9 travel bag for transport.

Note: The above are general warnings and cautions. Specific warnings, cautions and notes appear with the relevant instructions in the manual.

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Welcome

The S9 VPAP Tx provides continuous positive airway pressure (CPAP) and bilevel therapy.

The S9 VPAP Tx is a component of the S9 VPAP Tx Lab System. The S9 VPAP Tx Lab System provides remote PC control of a positive airway pressure therapy device (therapy device) capable of delivering multiple therapy modes. The system comprises:

1.S9 VPAP Tx or other compatible ResMed therapy device

2.Tx Link connection module

3.EasyCare Tx titration software.

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This guide provides instructions for the S9 VPAP Tx. Refer to the Tx Link Quick Setup Guide and EasyCare Tx Online Help for instructions on their use.

S9 VPAPTx indications for use

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30 lb (13 kg); all other modes are indicated for patients weighing more than 66 lb (30 kg).

The S9 VPAP Tx is intended to be used in a clinical environment.

S9 VPAPTx 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.

S9 VPAPTx adverse effects

Patients should report unusual chest pain, severe headache or increased breathlessness to the clinician. 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

•• bloating

•• ear or sinus discomfort

•• eye irritation

•• skin rashes.

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S9 VPAPTx at a glance

Module/Adapter port

DC power inlet

Air filter

Air outlet

The S9 VPAP Tx system comprises the following elements:

•• S9 VPAP Tx device

•• H5i heated humidifier

•• ClimateLine™ heated air tubing

•• 90W power supply unit

•• S9 travel bag

•• S9 USB Adapter. Optional components include:

•• Standard air tubing

•• SlimLine™ air tubing

•• ClimateLineMAX ™ heated air tubing

•• 3 m air tubing

•• Antibacterial filter.

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Masks

Mask systems recommended for use with the S9 VPAP Tx can be found at www.resmed.com. For information on using a mask refer to the mask user guide.

For a complete list of recommended masks and their settings go to www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.

CAUTION

Non-vented masks should not be used with the device.

Supplemental oxygen

Supplemental oxygen can be used with the S9 VPAP Tx. For more information, see “Adding supplemental oxygen” on page 22.

Antibacterial filters

Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure, particularly at high flows. ResMed has tested and recommends using an antibacterial filter with a low impedance (eg, 2 cm H2O at 60 L/min).

Humidifier

The S9 VPAP Tx is compatible with the H5i heated humidifier. For further information on using this humidifier refer to the H5i user guide.

USB Adapter

The S9 USB Adapter is designed for use with the S9 VPAP Tx. The USB adapter connects the S9 VPAP Tx to a personal computer via Tx Link for remote monitoring and control. For further information on using this adapter refer to the S9 USB Adapter user guide.

Climate Control

The S9 VPAP Tx, when used in conjunction with the H5i and ClimateLine or ClimateLineMAX heated air tubing, offers a feature called Climate Control.

Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient’s upper airway while protecting against rainout and allowing patients to select the air temperature that offers the most comfort for them.

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Therapy modes

The following table describes the therapy modes available on the S9 VPAP Tx.

Therapy mode	Description
CPAP (Continuous Positive Airway	Delivers a fixed pressure with optional Expiratory
Pressure)	Pressure Relief (EPR). EPR can improve patient comfort.
AutoSet	Delivers CPAP therapy with optional Expiratory Pressure
	Relief (EPR). Automatically adjusts the CPAP pressure in
	response to snore, flow limited breaths and apneas.
VAuto	Automatically adjusts pressure in response to flow
	limitation, snore and apneas. Pressure Support (PS) is
	fixed throughout the night and can be set by the clinician.
	Min EPAP and Max IPAP restrict the delivered pressure
	range.
Bilevel	Provides for control over a number of related bilevel
	therapy modes—S, S/T and T. In all cases you may set
	two treatment pressures— one for inspiration (IPAP) and
	one for expiration (EPAP). The difference between IPAP
	and EPAP levels is the pressure support.
S (Spontaneous)	Senses when the patient is inhaling and exhaling
	and supplies the appropriate pressures accordingly.
	The difference between IPAP and EPAP levels helps
	determine the tidal volume.
S/T (Spontaneous/Timed)	Augments any breath initiated by the patient, but will also
	supply additional breaths should the patient breath rate
	fall below the clinician's set backup respiratory rate.
T (Timed)	The fixed respiratory rate and the fixed inspiration/
	expiration time set by the clinician is supplied regardless
	of patient effort.
PAC (Pressure Assist Control)	The inspiration time is preset in the PAC mode. There
	is no spontaneous/flow cycling. The inspiration can be
	triggered by the patient when respiratory rate is above a
	preset value, or time triggered breath will be delivered at
	the backup breath rate.
ASV (Adaptive Servo-ventilation)	Treats central sleep apnea and/or mixed apneas and
	periodic breathing. In ASV mode, the expiratory positive
	airway pressure (EPAP) is adjusted by the clinician to
	maintain upper airway patency, while Min PS and Max
	PS restricts the range of automatically adjusted pressure
	support.
ASVAuto (Automatic Adaptive	Treats central sleep apnea and/or mixed apneas and
Servo-ventilation)	periodic breathing. In ASVAuto mode, the expiratory
	airway pressure (EPAP) is automatically adjusted to
	maintain upper airway patency between the limits set
	by Min EPAP and Max EPAP, while Min PS and Max PS
	restrict the range of automatically adjusted pressure
	support.
iVAPS (intelligent Volume-Assured	Maintains a preset target alveolar minute ventilation by
Pressure Support)	monitoring delivered ventilation, adjusting the pressure
	support and providing an intelligent backup breath
	automatically.

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S9 VPAPTx basics

Info menu button

LCD screen

Start/Stop button

Setup menu button	Alarm mute	Alarm and
	button	therapy LEDs
Push dial

		Key	Function
		Start/Stop button	Starts or stops treatment.
			Power Save mode—hold for three seconds.
		Info menu button	Allows you to view the device service information or to exit from
			the menu.
		Setup menu button	Allows you to make changes to settings or to exit from the menu.
			Turning the dial allows you to scroll through the menu and change
		Push dial	settings. Pushing the dial allows you to enter into a menu and
			confirm your choice.
			Press once to mute alarms. Press a second time to un-mute. If
		Alarm mute button	the problem is still present, the alarm will sound again after two
			minutes.
			Displays the menus, treatment screens and reminders.
		LCD screen	Backlight—when treatment is being delivered, the backlight
			(including the Start/Stop button) automatically turns off after
			30 seconds, otherwise it turns off after 3 minutes.
		Alarm LED	Yellow LED—flashes during an alarm.
		Therapy LED	Blue LED—always on during therapy (if enabled in the Options
			menu).

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Setting up the S9 VPAPTx

Module/Adaptor Port

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To Tx Link

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WARNING

•• Make sure the power cord and plug are in good condition and the equipment is not damaged.

•• Keep the power cord away from hot surfaces.

•• Do not leave long lengths of air tubing around the top of the patient’s bed. It could twist around the patient’s head or neck while they are sleeping.

•• Do not use electrically conductive or antistatic air tubings.

•• Do not use the air tubing if there are any visible signs of damage.

•• Only ResMed products are designed to be connected to the module connector port. Connecting other devices could damage the device.

CAUTION

•• Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is correctly set up.

•• Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord.

•• The H5i should only be connected or disconnected when the water tub is empty.

•• Always place the H5i on a level surface below the level of the user to prevent the mask and tubing from filling with water.

The S9 VPAP Tx is compatible with the integrated H5i heated humidifier. For further information on using this humidifier refer to the H5i user guide.

1.Align the H5i with the S9 VPAP Tx and push them together until they click into place.

2.Connect the DC plug of the power supply unit to the rear of the S9 VPAP Tx.

3.Connect the power cord to the power supply unit.

4.Plug the USB Module into the Module/Adaptor port at the rear of the S9 VPAP Tx.

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5.Connect the S9 VPAP Tx to the Tx Link via USB serial cable.

6.Plug the other end of the power cord into the power outlet.

7.Connect one end of the air tubing firmly onto the air outlet.

8.Connect the assembled mask system to the free end of air tubing.

The S9 VPAP Tx does not use the SD Card function to store data. All necessary data is transferred via Tx Link and available through the EasyCare Tx software.

Notes:

•• Always ensure that the S9 VPAP Tx is placed in an area where the alarm LED indicators are clearly visible.

•• Place the power supply unit away from the H5i to allow for adequate ventilation.

Filling the water tub

WARNING

Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in water. In the event of a spill, disconnect the device from the power supply and let the parts dry. Always unplug the device before cleaning and make sure that all parts are dry before plugging in the device.

CAUTION

•• Do not overfill the water tub as water may enter the device and air tubing.

•• Do not use any additives (eg, scented oils and perfumes).These may reduce the humidification output of the H5i and/or cause deterioration of the water tub materials.

•• Take care when handling the H5i as the water/water tub may be hot. Allow 10 minutes for the heater plate and any excess water to cool.

•• If liquids are inadvertently spilled into or on the H5i, unplug the device from the power outlet. Disconnect the H5i from the device and allow it to drain and dry before re-using.

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