VPAP III ST-A User Guide May 2010

G USING A HUMIDAIRE HUMIDIFIER

H USING A PASSOVER HUMIDIFIER

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REPLACING THE AIR FILTER

(21”)

(21”)

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1

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2 (6’6”/9’10”)

(6’6”/9’10”)

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248182 Illustrations.indd 2

4 3 © 2010 ResMed Ltd.

© 2010 ResMed Ltd.

4 © 2010 ResMed Ltd.

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23/04/2010 9:47:24 AM

VPAP™ III ST-A User Manual English

Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK See www.resmed.com for other ResMed locations worldwide. Protected by patents: AU 697652, AU 699726, AU 713679, AU 2002233025, CA 2235939, CN ZL02804936.5, EP 0661071, EP 0858352, HK 1065483, JP 3638613, JP 4083154, US 5199424, US 5522382, US 6213119, US 6240921, US 7614398. Other patents pending. Protected by design registrations: AU 147283, AU 147335, AU 147336, CH 128.709, CH 128.710, CH 128.711, CH 128.712, DE 40201723, DE 40202007, DE 40202008, DE 40202020, ES 153514, ES 153515, ES 153516, ES 153518, ES 156135, ES 156136, FR 02 1407, GB 3001791, GB 3001819, GB 3001820, GB 3001821, JP 1164087, JP 1164265, JP 1164266, JP 1164267, JP 4420605, NZ 527088, SE 75598, SE 75599, SE 75600, SE 75715, US D467335, US D468011, US D476077, US D477868, US D487311, US D503796. Other designs pending IPAP MAX, IPAP MIN, SmartStart, TiCONTROL, VPAP, and Vsync are trademarks of ResMed Ltd and IPAP MAX, SmartStart, and VPAP are registered in U.S. Patent and Trademark Office. © 2010 ResMed Ltd.

Contents Introduction... 1 User/Owner Responsibility

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Medical Information... 1 Indications for Use Contraindications Warnings Cautions

1 1 2 3

The VPAP III ST-A System... 4 Masks Humidifiers Accessories

4 4 5

Setting up the VPAP III ST-A System... 6 Setting up the VPAP III ST-A Attaching a Humidifier Using the LCD Screen and Keypad

6 7 9

Starting Treatment... 11 Stopping Treatment Using the HumidAire 2i Warm-up Feature Using the Mask-Fitting Feature

12 12 12

Cleaning and Maintenance... 14 Daily Cleaning Weekly Cleaning Periodic Cleaning Testing the Alarm Replacing the Air Filter Servicing

14 14 14 15 15 15

How to Use the VPAP III ST-A Menus... 17 Ramp Screen How to Use the Standard Menu How to Use the Detailed Menu (if enabled by your clinician) Menu Functions (Detailed Menu only) Treatment Screens Non-vented Mask Alarm Screen

17 17 18 20 23 25

The Alarms... 26 Alarms Troubleshooting

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Helpful Hints... 30 Troubleshooting... 32 System Specifications... 34 Contents

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Limited Warranty... 41

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Introduction The VPAP™ III ST-A is a bilevel pressure support ventilator specifically designed for non-invasive mask ventilation. This user manual contains the information you need for the correct use of your VPAP III ST-A.

User/Owner Responsibility The user or owner of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from: • operation which is not in accordance with the operating instructions supplied • maintenance or modifications carried out unless in accordance with authorized instructions and by authorized persons. Please read this manual carefully before use. This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information. • Warning alerts you to possible injury. • Caution explains special measures for the safe and effective use of the device. • Note is an informative or helpful note.

Medical Information Indications for Use The VPAP III ST-A system is intended to provide non-invasive ventilation for adult patients (>66 lb) and pediatric patients aged 7 years or older (>40 lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.

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CAUTION (USA ONLY) Federal law restricts this device to sale by or on the order of a physician.

Contraindications The VPAP III ST-A should not be used if you have an insufficient respiratory drive to endure brief interruptions in non-invasive ventilation therapy. The VPAP III ST-A is not a life support ventilator and may stop operating with power failure or in the unlikely event of certain fault conditions. If you have any of the following conditions, tell your doctor before using the VPAP III ST-A: • acute sinusitis or otitis media • epistaxis causing a risk of pulmonary aspiration

Introduction

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conditions predisposing to a risk of aspiration of gastric contents impaired ability to clear secretions • hypotension or significant intravascular volume depletion • pneumothorax or pneumomediastinum • recent cranial trauma or surgery. • •

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Warnings The entire manual should be read before using the VPAP III ST-A. Advice contained in this manual should not supersede instructions given by the prescribing physician. • The VPAP III ST-A should only be used with masks (and connectors)* recommended by ResMed, or by your physician or respiratory therapist. A mask should not be used unless the VPAP III ST-A is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked. Explanation of the warning: The VPAP III ST-A 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, enough fresh air will not 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 and bilevel devices. • •

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

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In the event of power failure or machine malfunction, remove the mask. Children who are unable to remove the mask should be attended at all times during therapy. At low EPAP pressures, the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur. The air flow for breathing produced by this device can be as much as 11oF higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90oF. The VPAP III ST-A can be set to deliver pressures up to 30 cm H2O. In the unlikely event of certain fault conditions, pressures up to 40 cm H2O are possible. The VPAP III ST-A is not suitable for use in the vicinity of flammable anesthetics. The VPAP III ST-A should not be used with anesthetized patients, whose breathing depends on artificial ventilation. If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating.

Explanation of the warning: When the device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen accumulated in the device enclosure will create a risk of fire. This warning applies to most types of flow generators. • Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. • Always ensure air flow is being generated by the device before the oxygen supply is turned on. • Always turn the oxygen supply off before stopping the air flow from the device. Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on where the oxygen is introduced, pressure settings, patient breathing pattern, mask selection, and leak rate. This warning applies to most types of CPAP and bilevel devices. Do not use the VPAP III ST-A if there are obvious external defects, unexplained changes in performance, or unusual noises. • Do not open the VPAP III ST-A case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent. •

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Cautions You should report unusual chest pain, severe headache, or increased breathlessness to your 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 VPAP III ST-A: • drying of the nose, mouth, or throat • bloating • ear or sinus discomfort • eye irritation • skin rashes • chest discomfort. The above are general warnings and cautions. Further specific warnings, cautions, and notes appear next to the relevant instructions in the manual.

Medical Information

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The VPAP III ST-A System Please refer to the illustrations in section A of the illustration sheet. Please identify and familiarize yourself with the following components of the VPAP III ST-A: • VPAP III ST-A front view (A-1) • VPAP III ST-A rear view (A-2) • Power cord (A-3) • Carry bag (A-4) • 6’6" air tubing (A-5).

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WARNING Do not connect any device to the auxiliary port. Although your health care provider may connect or have you connect specially designed devices to the auxiliary port of the VPAP III ST-A, connection of other devices could result in injury, or damage to the unit. • In the home environment, the only device that may be connected to the communications port is a modem that is locally approved. Locally approved modems may also be connected in the clinical environment. • In the clinical environment any PC that is used with the VPAP III ST-A system must be at least 5’ away from, or at least 8’ above the patient. It must also comply with IEC 60950 or equivalent. •

Masks You will also need a ResMed mask system (supplied separately). For the latest available masks, see www.resmed.com. This device requires a specific mask setting; refer to your mask User Guide for the mask setting you should use. For information on using your mask, refer to the user guide supplied with your mask. Notes: • ResMed VPAP III ST-A has been designed and manufactured to provide optimum performance using ResMed vented mask systems. While other vented mask systems may be used, performance and data outputs may be affected. • Not all masks are available in all regions.

Humidifiers Please refer to the illustrations in section B of the illustration sheet. A humidifier may be required if you are experiencing dryness of the nose, throat or mouth. The VPAP III ST-A is compatible for use with the following humidifiers: • HumidAire 2i™ heated humidifier (B-1) • HumidAire 2iC™ passover humidifier (B-2) 4

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HumidAire™ heated humidifier (B-3) ResMed Passover humidifier (B-4).

WARNING Only the HumidAire 2i, HumidAire 2iC, HumidAire heated humidifier and the ResMed Passover are compatible for use with the VPAP III ST-A. Please refer to Warnings on page 2.

Accessories Please refer to the illustrations in section C of the illustration sheet. The following accessories may be purchased separately: • 9’10" air tubing (C-1) • Medium (21") air tubing for the HumidAire and ResMed Passover humidifiers (C-2) • Hypoallergenic air filter. Note: ResMed regularly releases new products. Please check our website at www.myresmed.com.

The VPAP III ST-A System

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Setting up the VPAP III ST-A System Please refer to the illustrations in section D of the illustration sheet.

Setting up the VPAP III ST-A 1 Place the VPAP III ST-A on a flat surface near the head of your bed. If the device is placed on the floor, ensure that the area is free from dust and clear of bedding, clothes or any other objects that could block the air inlet.

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

2 Connect the power cord There are two sockets at the rear of the flow generator-the top one for an AC (standard mains electricity) and the lower one for a DC power cord (see “Using a Battery to Power the VPAP III ST-A” on page 30). ResMed recommends using the AC power cord supplied with the unit. If the customized ResMed power cord is supplied, it can be held in place with the locking clips. To insert the locking clip, pinch the free ends together and fit the pins into the holes on both sides of the socket. Insert the power cord into the socket. Push the locking clip down so that the groove holds the power cord in place. Power switch AC locking clip

AC power cord

Plug the free end of the power cord into a power outlet (D-1).

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CAUTION Do not connect both AC and DC power cords to the VPAP III ST-A at the same time.

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WARNING Make sure the power cord and plug are in good condition and the equipment is not damaged. • The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure that the air filter and air filter cover are fitted at all times. •

3 Connect one end of the air tubing firmly onto the air outlet of the VPAP III ST-A (D-2).

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WARNING Only ResMed air tubing should be used with your flow generator. A different type of air tubing may alter the pressure you actually receive and reduce the effectiveness of your treatment.

4 Assemble your mask system according to the mask user instructions. 5 Connect your mask system to the free end of the air tubing (D-3). The VPAP III ST-A system is now assembled (D-4). To start treatment, see “Starting Treatment” on page 11.

Attaching a Humidifier !

WARNING When using a humidifier, position it lower than you, and at the same level or lower than the VPAP III ST-A. Note: You must activate the humidifier option in the menus if you are using a HumidAire or Passover humidifier.

Attaching a HumidAire 2i Humidifier Please refer to the illustrations in section E of the illustration sheet. The HumidAire 2i attaches to the front of the VPAP III ST-A to provide heated humidification. No other accessories are required for its use. The VPAP III ST-A automatically detects the presence of the HumidAire 2i. No menu changes are required. Please refer to the HumidAire 2i User’s Manual for details.

Attaching a HumidAire 2iC Humidifier Please refer to the illustrations in section F of the illustration sheet. The HumidAire 2iC attaches to the front of a VPAP III ST-A to provide passover humidification. No other accessories are required for its use. Please refer to the HumidAire 2iC User’s Manual for details.

Attaching a HumidAire Humidifier Please refer to the illustrations in section G of the illustration sheet. Medium size (21") air tubing is a necessary accessory for connecting the VPAP III ST-A to the HumidAire humidifier.

Setting up the VPAP III ST-A System

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To set up the VPAP III ST-A with the HumidAire: 1. Fill the HumidAire with water as described in the humidifier manual. 2. Place the filled water chamber inside the HumidAire. Connect the medium (21") air tubing to the right connector port, and the long air tubing (6’6" or 9’10") to the left connector port on the humidifier (G-1). Close the HumidAire lid. 3. Place the VPAP III ST-A on top of the HumidAire (G-2). Do not place the VPAP III ST-A underneath the humidifier. (This is to avoid water spilling into the device which may cause severe and costly damage.) 4. Connect the free end of the medium air tubing to the air outlet of the VPAP III ST-A (G-3). 5. Connect the mask system to the free end of the long air tubing. The final assembly should look like illustration G-4. 6. Plug the HumidAire power cord into a power outlet. 7. If the VPAP III ST-A is not already plugged in, see Step 2 on page 6.

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WARNING Make sure that the power cord and plug are in good condition and the equipment is not damaged. 8. Navigate to the humidifier setting (if available) in the VPAP III ST-A menu and select "HUMIDAIRE". See “How to Use the Detailed Menu (if enabled by your clinician)” on page 18. The VPAP III ST-A is now ready for use with the HumidAire. To start treatment, see “Starting Treatment” on page 11.

Attaching a Passover Humidifier Please refer to the illustrations in section H of the illustration sheet. Medium size (21") air tubing is a necessary accessory for connecting the VPAP III ST-A to the ResMed Passover humidifier. To set up the VPAP III ST-A with the ResMed Passover: 1. Fill the Passover with water as described in the humidifier manual. 2. Connect the medium (21") air tubing to the right connector port, and the long air tubing (6’6" or 9’10") to the left connector port on the humidifier (H-1). 3. Place the VPAP III ST-A on top of the Passover (H-2). Do not place the VPAP III ST-A underneath the humidifier. (This is to avoid water spilling into the device which may cause severe and costly damage.) 4. Connect the free end of the medium air tubing to the air outlet of the VPAP III ST-A (H-3). 5. Connect the mask system to the free end of the long air tubing. The final assembly should look like illustration H-4. 6. If the VPAP III ST-A is not already plugged in, see Step 2 on page 6.

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WARNING Make sure that the power cord and plug are in good condition and the equipment is not damaged. 7. Navigate to the humidifier setting (if available) in the VPAP III ST-A menu and select "PASSOVER". See “How to Use the Detailed Menu (if enabled by your clinician)” on page 18. The VPAP III ST-A is now ready for use with the ResMed Passover. To start treatment, see “Starting Treatment” on page 11.

Using the LCD Screen and Keypad The control panel of the VPAP III ST-A includes an LCD screen, LEDs and keypad. LCD screen

QuickView

LEDs

Left key (green)

Right key (red)

Start/Stop

Alarm Mute

Up/down key

LCD Screen The LCD screen displays the menus, treatment screens and alarm conditions.

To assist you in adjusting the VPAP III ST-A, the keypad and LCD are equipped with a backlight. The LCD backlight comes on when the device is turned on or when you press a key, and turns off after two minutes.

LEDs The LEDs display the status of the VPAP III ST-A when active. Green/Red Yellow

The Green LED may be on during treatment, if enabled by your clinician. The Yellow or Red LEDs are on during an alarm condition.

Setting up the VPAP III ST-A System

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Keypad Keys The VPAP III ST-A keypad has the following keys: Key

Function

Start/Stop

• Starts or stops treatment. • Extended hold for at least three seconds starts the Mask­Fitting feature.

Up/Down

• Allows you to scroll through the VPAP III ST-A menus, submenus and setting options.

Left (green)

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes menu, enter, change and apply.

Right (red)

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes exit and cancel.

Alarm Mute

• Press once to mute alarms. If the problem is still present, the alarm will sound again after two minutes. See “Alarm Mute Key” on page 26.

QuickView

• Clinical menu function key. Clinical use only.

Keypad and LCD Backlight To assist you in adjusting the VPAP III ST-A, the keypad and LCD are equipped with a backlight. The LCD backlight comes on when the unit is turned on or when you press a key, and turns off after two minutes. Your clinician may have set the LCD backlight to be on continually. The keypad backlight is on at all times when the VPAP III ST-A is powered.

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Starting Treatment The VPAP III ST-A should be assembled beside your bed with the air tubing and mask system connected. See “Setting up the VPAP III ST-A” on page 6.

1 Turn the main power switch at the back of the device to on (I).

Main power switch

When the VPAP III ST-A is turned on, a welcome message is displayed on the LCD screen. The VPAP (or Ramp) screen then appears. Note: If you have the HumidAire 2i attached, see “Using the HumidAire 2i Warm-up Feature” on page 12.

2 Fit your mask as described in the mask user instructions. 3 Lie down and arrange the air tubing so that it is free to move if you turn in your sleep.

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CAUTION Do not leave long lengths of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping. • Make sure the area around the flow generator is dry and clean. It should also be clear of bedding, clothes and other potential blockages. •

4 To start treatment, press the Start/Stop key or if your clinician has enabled the SmartStart function, simply breathe into the mask and treatment will begin. After starting treatment, you can display one of the treatment screens described in “Treatment Screens” on page 23.

Ramp Time Ramp time is a feature which can be enabled by your clinician. If you have difficulty falling asleep with full pressure, select a ramp time. The airflow will start very gently while you fall asleep. The pressure will slowly increase to full operating pressure over the selected ramp time. The clinician has set a maximum ramp time; you may select any value up to the maximum. To select a ramp time, see “Ramp Screen” on page 17.

Starting Treatment

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Stopping Treatment To stop treatment at any time, remove your mask and press the Start/Stop key or if your clinician has enabled the SmartStart function, simply remove your mask and treatment will end (SmartStop is not applicable with the "Mir Full" mask setting).

Using the HumidAire 2i Warm-up Feature If using a HumidAire 2i with the VPAP III ST-A, you can use the Warm-up feature to pre-heat the water in the humidifier prior to starting treatment. After stopping treatment, the VPAP III ST-A will continue to blow air gently to assist cooling of the heater plate. See the HumidAire 2i User’s Manual for further details.

Using the Mask-Fitting Feature The VPAP III ST-A mask-fitting feature can be used to help you fit your mask properly. The mask-fitting feature delivers air pressure for a three-minute period, prior to starting treatment, for checking and adjusting your mask fit to minimize leaks. If a ramp time is selected, the mask can be adjusted at a pressure closer to the prescribed pressure. To use the mask-fitting feature: 1. Fit your mask as described in the user instructions. 2. Hold down the Start/Stop key for at least three seconds until air pressure delivery starts. The following display will appear on the LCD screen indicating that the mask­fitting feature is in operation. The flow generator will ramp to the Mask­Fit pressure and will remain at this pressure for three minutes. A Mask­Fit star rating is also displayed. See “Definitions of Mask-Fit Star Rating” on page 13. Mask Fit excelnt

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Mask-Fit star rating

Notes: The Mask-Fit star rating display disappears after three minutes. • The mask-fitting feature can only be started from the VPAP (or Ramp) screen. • The Mask-Fit pressure is the set treatment pressure or 10 cm H20, whichever is greater. 3. Adjust your mask, mask cushion and headgear until you have a secure and comfortable fit. •

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Once you have a secure and comfortable fit, check your Mask-Fit star rating on the LCD screen. Definitions of the Mask-Fit star ratings are presented in Table 1. Note: If there is another person nearby to check your Mask-Fit star rating, you can adjust your mask, mask cushion and headgear while lying down. 4. After three minutes, treatment will begin. • If you do not wish to wait three minutes, hold down the Start/Stop key for at least three seconds and treatment will begin immediately. • If you press the Start/Stop key for less than three seconds, the VPAP III ST-A will return to standby mode (the VPAP or Ramp screen is displayed). Table 1: Definitions of Mask-Fit Star Rating Star rating

Definition

*****

Excellent

****-

Very good

***--

Good

**---

Adjust mask

*----

Adjust mask

HIGH LEAK

Adjust mask

Starting Treatment

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Cleaning and Maintenance You should regularly carry out the cleaning and maintenance described in this section.

Daily Cleaning Mask Clean the mask according to the instructions supplied with the mask.

Air tubing Disconnect the air tubing from the VPAP III ST-A (and humidifier, if used) and hang the tubing and mask in a clean, dry place until next use.

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CAUTION Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack.

Humidifier If you are using a humidifier, clean it according to the instructions in the humidifier user manual.

Weekly Cleaning 1. Remove the air tubing from the VPAP III ST-A and the mask. 2. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang and allow to dry. 3. Before next use, assemble the mask and headgear according to the user instructions. 4. Reconnect the air tubing to the air outlet and mask.

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CAUTION Do not use bleach, chlorine-, alcohol- or aromatic-based solutions (including all scented oils), moisturizing or antibacterial soaps to clean the air tubing or the VPAP III ST-A. These solutions may cause hardening and reduce the life of the product. • Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack. •

Periodic Cleaning 1. Clean the exterior of the VPAP III ST-A with a damp cloth and mild liquid soap. 2. Inspect the air filter to check if it is blocked by dirt or contains holes. See “Replacing the Air Filter” on page 15.

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