VPAP Adapt SV User Guide Aug 2010

228234 VPAP Adapt SV User Guide USA Eng.book Page 3 Monday, October 13, 2008 2:15 PM

VPAP™ Adapt SV The VPAP Adapt SV flow generator has been designed to be reliable, comfortable and easy to use. You can observe your treatment and make adjustments to settings using a keypad and LCD screen.

!

English

Introduction

CAUTION USA federal law restricts this device to sale by or on the order of a physician.

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.

Definitions ! !

WARNING Alerts you to possible injury.

CAUTION Explains special measures for the safe and effective use of the device.

Medical Information Intended Use The VPAP Adapt SV system is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing. This device is intended for use in the hospital or home.

Contraindications The VPAP Adapt SV is not a life support ventilator and may stop operating with power failure or in the unlikely event of certain fault conditions. Before using the VPAP Adapt SV tell your doctor if you have any of the following conditions: • hypotension or significant intravascular volume depletion • acute sinusitis or otitis media • epistaxis (severe nosebleeds) causing a risk of pulmonary aspiration • conditions predisposing to a risk of vomiting into mask

Introduction

3

228234 VPAP Adapt SV User Guide USA Eng.book Page 4 Monday, October 13, 2008 2:15 PM

impaired ability to clear secretions pneumothorax or pneumomediastinum • recent cranial trauma or surgery • chronic hypoventilation. Below are general warnings and cautions. Further specific warnings, cautions and notes appear next to the relevant instructions in the manual. • •

!

WARNINGS • • • •

•

• •

•

• •

• •

!

4

The VPAP Adapt SV is NOT a life support ventilator. The entire manual should be read before using the VPAP Adapt SV. Advice contained in this manual should not supersede instructions given by the prescribing physician. The VPAP Adapt SV should be used with masks and accessories recommended by ResMed or the prescribing physician. Use of incorrect masks and accessories may adversely affect the function of the VPAP Adapt SV. The VPAP Adapt SV is designed for use with masks that allow exhaled gases to be flushed out through vent holes. Exhaled gases will be rebreathed if the mask is worn with the machine turned off, or the vent holes are occluded. If this occurs over prolonged periods, suffocation may occur. In the event of power failure or machine malfunction, remove the mask. The air flow for breathing produced by this device can be as much as 11ºF (6ºC ) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90ºF (32ºC). The VPAP Adapt SV can be set to deliver pressures up to 25 cm H2O. In the unlikely event of certain fault conditions, pressures of up to 40 cm H2O for less than one second are possible. The VPAP Adapt SV is not suitable for use in the vicinity of flammable anesthetics. If oxygen is used with the VPAP Adapt SV, the oxygen flow should be stopped when the device is not operating. If oxygen flow continues when the device is not operating, oxygen may accumulate within the device and create a risk of fire. Do not use the VPAP Adapt SV if there are obvious external defects or unexplained changes in performance. Do not open the VPAP Adapt SV case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent.

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 a course of therapy with the VPAP Adapt SV: • drying of the nose, mouth, or throat • bloating • ear or sinus discomfort • eye irritation • skin rashes • chest discomfort.

English

228234 VPAP Adapt SV User Guide USA Eng.book Page 5 Monday, October 13, 2008 2:15 PM

Quick Setup Guide 1 Attach the air tubing and pressure sensor tube to the VPAP Adapt SV and mask (page 9).

2 Attach a humidifier if required (page 10). 3 Switch on the VPAP Adapt SV. Make sure the mask is unblocked. 4 Select the mask setting (page 21). 5 Perform the Air Circuit Learn function (page 21) at first-time use, or if you are

adding or removing a component of the system (eg, a humidifier or anti-bacterial filter).

6 Fit the mask and commence breathing into it. The SmartStart™ function should trigger treatment to commence within the first couple of breaths. If not, press the Start/Stop key once to commence treatment (page 16). Note: You can observe treatment progress (eg, mask leak) via the Treatment screens (page 24).

Quick Setup Guide

5

228234 VPAP Adapt SV User Guide USA Eng.book Page 6 Monday, October 13, 2008 2:15 PM

7 Remove your mask to stop treatment. If SmartStop is enabled, treatment will stop automatically. If the SmartStop function has been disabled, press the Start/Stop key once.

VPAP Adapt SV System VPAP Adapt SV Components The VPAP Adapt SV flow generator is supplied with air tubing and a power cord. Masks are supplied separately, as you and your clinician have to decide which mask is best for you. Some people experience dryness of the nose, mouth and throat while using the VPAP Adapt SV system, especially during winter. Others may experience sneezing and/or a runny or blocked nose during the first few weeks of VPAP treatment. In many cases, these symptoms of nasal irritation can be resolved with a humidifier. See page 10 to connect a humidifier to the VPAP Adapt SV. LCD screen Control panel Carry handle Removable front cover

Pressure sensor tube connector

Air tubing connector

Figure 1: VPAP Adapt SV flow generator

The control panel allows you to adjust settings on the flow generator, and the LCD screen displays information about your treatment. See “Control Panel Functions” on page 17.

6

ResLink attachment point

English

228234 VPAP Adapt SV User Guide USA Eng.book Page 7 Monday, October 13, 2008 2:15 PM

Air filter Power cord

Figure 2: Rear of VPAP Adapt SV

See page 14 to connect a ResLink™. See page 30 to replace the air filter. Proximal cuff

Connect this end to the mask

Tube clip

Pressure sensor tube

Air tubing

Luer connector

Connect this end to the flow generator

Figure 3: Air tubing fully assembled

All necessary air tubing components are packed with the VPAP Adapt SV: • a 6’6" (2 m) length of air tubing • a pressure sensor tube (to measure pressure at the mask) with Luer connectors • tube clips (to hold the pressure sensor tube onto the air tubing) • a proximal cuff (a special connector that attaches the pressure sensor tube into the main air tubing so you only need to make one attachment to the mask). The air tubing is supplied with the proximal cuff connected. Attach the tube clips evenly along the air tubing. Press the pressure sensor tube into the tube clips, and screw the Luer connectors together at the proximal cuff. Make sure the pressure sensor tube is not kinked, obstructed or twisted. Note: ResMed recommends the following tubing products for use with the VPAP Adapt SV: replacement air hose (only) PN14986; replacement air delivery system (hose, sensor line, clips, proximal cuff) PN26923.

Masks You will also need a ResMed mask system (supplied separately). For the latest available masks, see www.resmed.com. Please refer to the table on page 21 to set up your mask correctly for use with the VPAP Adapt SV. Your clinician can explain the features of the masks available and will discuss the mask that best suits your needs.

VPAP Adapt SV System

7

228234 VPAP Adapt SV User Guide USA Eng.book Page 8 Monday, October 13, 2008 2:15 PM

Assembling the VPAP Adapt SV System Complete the following steps to assemble the VPAP Adapt SV system. Make sure the area around the unit is clean (dust free) and clear of bedding, clothes and any other potential blockages. To add a humidifier see page 10.

!

WARNING Use only the air tubing system supplied with the VPAP Adapt SV system.

1 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 DC Power to Run the VPAP Adapt SV” on page 15). ResMed recommends using the AC power cord supplied with the unit. The customized ResMed power cord 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. Plug one end of the power cord into the power socket at the rear of the unit, and the other end into a power outlet. Power switch AC locking clip

AC power cord

Plug the free end of the power cord into a power outlet.

!

!

8

CAUTIONS Do not connect both AC and DC power cords to the VPAP Adapt SV at the same time. • Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord. •

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

228234 VPAP Adapt SV User Guide USA Eng.book Page 9 Monday, October 13, 2008 2:15 PM

Connect the air tube firmly onto the air outlet at the front of the unit.

Air tubing connector Pressure sensor tube connector

English

2 Connect air tubing

Figure 4: Front view of VPAP Adapt SV

To attach the pressure sensor tube to the unit, screw the Luer connector onto the socket on the side of the unit.

Figure 5: Twisting the Luer lock connectors together

!

WARNING Use care when handling the air tubing. Be particularly careful when attaching the Luer connector to the VPAP Adapt SV. If you kink or excessively twist the sensor tube it may affect the protection offered by the mask pressure alarm system.

3 Attach the mask to the air tubing. The mask system should already be assembled. If it is not, please refer to the user instructions supplied with the mask. Connect the mask system to the free end of the air tubing.

Proximal cuff

Figure 6: Assembling the VPAP Adapt SV system

VPAP Adapt SV System

9

228234 VPAP Adapt SV User Guide USA Eng.book Page 10 Monday, October 13, 2008 2:15 PM

Humidifiers A humidifier may be required if you are experiencing dryness of the nose, throat, or mouth. The following ResMed humidifiers are compatible with the VPAP Adapt SV:

HumidAire

HumidAire 2i

heated humidifier

heated humidifier

Humidifier accessory (HumidAire only) Medium air tubing 21" (52 cm)

Figure 7: Humidifiers compatible with the VPAP Adapt SV

When using a humidifier, stop the VPAP Adapt SV by using the Start/Stop key or by removing the mask to trigger the SmartStop function. Do not switch the VPAP Adapt SV off at the power switch or the power source while it is running, as this could result in condensation in the motor. Please refer to the relevant humidifier user manual for detailed instructions and warnings.

!

CAUTIONS Be very careful not to allow water to enter the VPAP Adapt SV as this could affect therapy and/or damage the device. • Do not tip the humidifier while it is connected to the VPAP Adapt SV. If water enters the VPAP Adapt SV device, turn off the main power switch at the back of the unit and unplug it from the power outlet. Return the unit to your equipment supplier for checking. •

Connecting a Humidifier Note: After connecting or removing a humidifier, always perform the Air Circuit Learn function (see page 21).

!

10

WARNING When using a humidifier, position it so that it is lower than your head will be during sleep, and at the same level or lower than the VPAP Adapt SV.

228234 VPAP Adapt SV User Guide USA Eng.book Page 11 Monday, October 13, 2008 2:15 PM

The HumidAire 2i provides heated humidification for the VPAP Adapt SV. To attach the HumidAire 2i, remove the VPAP Adapt SV front cover and attach the humidifier docking station and water chamber. No other accessories are required for use. Please refer to the HumidAire 2i User’s Manual for details. Once you have performed the Air Circuit Learn function the VPAP Adapt SV is ready for use. See “Starting Treatment” on page 16.

HumidAire 2i docking station

English

HumidAire 2i™

VPAP Adapt SV

HumidAire 2i water chamber

Figure 8: HumidAire 2i attached to the VPAP Adapt SV

Figure 9: HumidAire 2i attached to VPAP Adapt SV and mask

!

WARNING Make sure that the water chamber is empty and thoroughly dried before transporting the HumidAire 2i. • When using the carry bag, always separate the VPAP Adapt SV unit and the Humidaire 2i before placing in their respective compartments. •

VPAP Adapt SV System

11

228234 VPAP Adapt SV User Guide USA Eng.book Page 12 Monday, October 13, 2008 2:15 PM

HumidAire™ You will need a medium size 21" (52 cm) air tube to connect the VPAP Adapt SV unit to the HumidAire™ (see Figure 7).

1 Make sure both the HumidAire and the VPAP Adapt SV are turned off. Fill the HumidAire with water as described in the humidifier manual. Place the filled water chamber inside the HumidAire.

2 Gently detach enough of the tube clips to release the end of the pressure sensor

tube from the VPAP Adapt SV air tubing. Connect the VPAP Adapt SV air tubing to the left connector port on the humidifier, and the medium 21" (52 cm) air tubing to the right connector port. Close the HumidAire lid.

Medium air tubing HumidAire

VPAP Adapt SV air tubing

Pressure sensor tube

3 Place the VPAP Adapt SV on top of the HumidAire. Never place the

VPAP Adapt SV unit underneath the humidifier. (This is to avoid water spilling into the unit.)

4 Connect the free end of the medium air tubing to the VPAP Adapt SV. Connect the pressure sensor tube by twisting the Luer lock onto the VPAP Adapt SV (see page 9).

12

English

228234 VPAP Adapt SV User Guide USA Eng.book Page 13 Monday, October 13, 2008 2:15 PM

5 Connect the mask system to the free end of the long air tubing. The final assembly should look like this:

6 Switch on the HumidAire and the VPAP Adapt SV.

!

WARNING Make sure that the power cords and plugs are in good condition and the equipment is not damaged.

7 Perform the Air Circuit Learn function (see page 21). For information about filling and maintaining your humidifier, refer to the HumidAire User’s Manual. The VPAP Adapt SV is now ready for use with the HumidAire. See “Starting Treatment” on page 16.

!

CAUTION Set up the HumidAire and the VPAP Adapt SV unit so that the tubing to the mask runs higher than the machines. This will prevent condensation build-up. • If condensation appears in the mask, turn the humidifier settings down. •

VPAP Adapt SV System

13

228234 VPAP Adapt SV User Guide USA Eng.book Page 14 Monday, October 13, 2008 2:15 PM

ResLink™ The ResLink is a device that records data onto a SmartMedia™ card during your therapy. The card can be returned to your clinician so that they can observe your progress and adjust flow generator parameters if necessary. The ResLink connects to the back of VPAP Adapt SV as shown. For full details on using the ResLink, please refer to the ResLink User’s Manual.

Anti-bacterial Filter Your clinician may recommend that you use an anti-bacterial filter. A filter should be placed in the air tubing between the mask and the flow generator. If using a humidifier, place the filter between it and the flow generator (see Figure 10 below). Typically, the filter should be replaced daily. Check the filter instructions for full details. Whenever a filter is added, removed or replaced you must run the Air Circuit Learn function (see “Learn Circuit” on page 21). Note: Only hydrophobic anti-bacterial filters should be used with a HumidAire 2i.

Anti-bacterial filters

Figure 10: Inserting anti-bacterial filters

14

228234 VPAP Adapt SV User Guide USA Eng.book Page 15 Monday, October 13, 2008 2:15 PM

The VPAP Adapt SV can be run on DC in case of power failure. ResMed supplies separately a converter that allows a 12V or 24V battery to be connected to the DC input of the VPAP Adapt SV. When using a DC power supply, the power is turned on and off via the switch on the converter, and not the power switch at the back of the VPAP Adapt SV. The DC converter is a separate accessory that can be purchased through your ResMed distributor. The humidifier heater will be automatically disabled when the VPAP Adapt SV is operating from the DC supply. Power consumption of the VPAP Adapt SV varies with treatment settings. Adequate battery type and sizing is required before operation on DC, and it is recommended that you contact ResMed’s Technical Services division or see ResMed's website for information on your specific application.

!

English

Using DC Power to Run the VPAP Adapt SV

CAUTION The VPAP Adapt SV uses 30V DC power. Only connect the VPAP Adapt SV to DC power using the VPAP Adapt SV DC Converter (P/N 26928) specified for this application.

Supplemental Oxygen The VPAP Adapt SV is designed to be compatible with the use of low flow oxygen therapy provided from an external source and supplied at a fixed rate of up to 15 L/min. At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate. This warning applies to most types of bilevel machines.

!

WARNING If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. Explanation: 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 and create a risk of fire. • Always begin VPAP Adapt SV therapy before the oxygen supply is turned on. • Always turn the oxygen supply off before stopping VPAP Adapt SV therapy. • Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. •

VPAP Adapt SV System

15

228234 VPAP Adapt SV User Guide USA Eng.book Page 16 Monday, October 13, 2008 2:15 PM

Using the VPAP Adapt SV !

WARNING Before starting therapy with a new mask, select the correct mask type in the Settings menu (page 21). When adding or removing a new component, such as a mask, humidifier, or anti-bacterial filter, perform the Air Circuit Learn function (page 21).

Starting Treatment When the system is fully assembled press the power switch at the back of the VPAP Adapt SV to ON. The Welcome screen will be displayed while the flow generator is warming up. Allow the unit to warm up for approximately 30 seconds before placing the mask on your face. WELCOME

Figure 11: Welcome screen

Once the VPAP Adapt SV has warmed up, breathing into the mask should start therapy immediately. If not, press the Start/Stop key once to commence treatment. The VPAP Adapt SV restarts in the mode in which it stopped.

Stopping Treatment If SmartStop is enabled, treatment will stop automatically when you remove your mask. If the SmartStop function has been disabled, press the Start/Stop key.

Standby Mode VPAP ADAPT SV menu

Figure 12: Standby screen

Once you have stopped treatment, the VPAP Adapt SV will be in standby mode. In standby you can: • press the power switch at the back to OFF to turn off the flow generator • commence treatment again by breathing into the mask or pressing the Start/Stop key • enter any of the menus by pressing the Left key. When in standby mode, a gentle (non-therapeutic) flow of air will still be present. Note: If the SMART DATA - AUTO APPEAR option is set to ON the screens available under the Results menu will be displayed automatically for approximately 20 minutes after your session is completed. 16

228234 VPAP Adapt SV User Guide USA Eng.book Page 17 Monday, October 13, 2008 2:15 PM

The control panel of the VPAP Adapt SV has a keypad that allows you to: • start or stop treatment • adjust settings on the flow generator • mute or stop alarms • view treatment data.

English

Control Panel Functions

LCD display

QuickView key

Alarm LEDs

Alarm mute key

Start/Stop key

Left key

Up/Down key

Right key

Figure 13: The VPAP Adapt SV control panel

LCD screen Displays information about flow generator settings, alarms and treatment. The LCD screen is backlit whenever any key is pressed. The lighting will turn off automatically when no button has been pressed for two minutes, or can be set to stay on (see “Options Menu” on page 23). An alarm message will overwrite any other message on the screen. The original screen will reappear when any key is pressed.

Start/Stop key •

Press the key once to start or stop treatment.

Up/Down key • •

Moves backwards and forwards within a menu and between menus. Increases and decreases values of parameters-press once to adjust in single increments; hold down to move quickly through the values.

Using the VPAP Adapt SV

17

228234 VPAP Adapt SV User Guide USA Eng.book Page 18 Monday, October 13, 2008 2:15 PM

Left key (green) Enters a menu. Confirms and applies settings. • Performs the function indicated by the text above it in the LCD (eg, ’enter’, ’change’). • •

Right key (red) Performs the function indicated by the text above it in the LCD (eg, ’exit’). Cancels operations. • Extended hold: exits to the top level of the menu. • •

QuickView key Takes you immediately to the Treatment screens, with information on your current therapy. See “Treatment Screens” on page 24.

Alarm LEDs and Alarm mute The Alarm LEDs are lights that indicate that an alarm has been triggered. Alarms can be muted by pressing the Alarm mute key once. The Alarm LEDs will remain lit for as long as the alarm is being triggered. See “Alarms” on page 25.

Adjusting Settings By using the Left, Right and Up/Down keys you can adjust some aspects of your treatment. The settings can be seen in the LCD display. To change a setting, press the Up/Down key until you arrive at the menu you require. • Press the Left key to enter the menu, then use the Up/Down key again to scroll through the options. • Once you find the option you require press the Left key to select the function that is displayed in the bottom left of the screen eg, ’change’, ’yes’. • Use the Up/Down key to alter the parameters and press the Left key when you have the setting you require. • Press the Right key to exit from the menu.

18

228234 VPAP Adapt SV User Guide USA Eng.book Page 19 Monday, October 13, 2008 2:15 PM

You wish to change the setting for the mask you are using. VPAP Adapt SV menu

SETTINGS enter 

Press ’down’ arrow on Up/Down key to move to next menu

English

Example

Press Left key to enter menu options exit

(ASV MODE)

MASK: FULL FACE change  exit

1. Press Left key to select ’change’.

LEARN CIRCUIT? yes exit 

3. Press Left key to enter setting.

SMARTSTOP: OFF change  exit

2. Press Up/Down key to reach setting. 4. Press Right key to exit.

SOUND LEVEL: LOW change  exit RESULTS enter 

exit

OPTIONS enter 

exit

SERVICING enter 

exit

Figure 14: Using the keys to adjust settings

Using the VPAP Adapt SV

19

228234 VPAP Adapt SV User Guide USA Eng.book Page 20 Monday, October 13, 2008 2:15 PM

Menus The options available in the Settings menu will depend on the therapy you are receiving (either ASV or CPAP), as set by your clinician. VPAP ADAPT SV menu

SETTINGS enter 

exit CPAP MODE

ASV MODE MASK: FULL FACE change  exit

RAMP: 20min change 

LEARN CIRCUIT? yes exit 

MASK: FULL FACE change  exit

SMARTSTOP: OFF change  exit

LEARN CIRCUIT? yes exit 

SOUND LEVEL: LOW change  exit

SMARTSTOP: OFF change  exit

exit

SOUND LEVEL: LOW change  exit

RESULTS enter 

exit MASK FIT: ***- good exit  AVG PRESS: 10.4 exit  USAGE: 4.56hrs exit 

SERVICING enter 

exit

SN: 1234567890123 4567 exit  PCB: 123456789012 exit  SW: SX432-0201 exit 

Figure 15: Navigating the Patient menu.

20

These menus appear only if at least one Smart Data option has been enabled by the clinician.

228234 VPAP Adapt SV User Guide USA Eng.book Page 21 Monday, October 13, 2008 2:15 PM

You will only see the options relevant to your therapy. In CPAP (Continuous Positive Airway Pressure) mode, the clinician sets a pressure that will be constant throughout treatment. In ASV mode, the VPAP Adapt SV continually measures your breathing and regulates the air pressure accordingly.

English

Settings Menu

Mask Select the type of mask that you will be using (you will only need to adjust this if you have more than one mask). The following table shows the setting that should be selected for each mask type. If your mask type is not mentioned below, please contact your clinician. Not all mask types can be used with the VPAP Adapt SV. Option in Settings menu

Use setting with:

Vista

Vista™

Ultra

Ultra Mirage™

Full Face

Mirage™ Full Face Mask Series II Ultra Mirage™ Full Face Mask Mirage Quattro™ Full Face Mask

Activa

Activa™

Selecting mask options in the Settings menu

Learn Circuit The Air Circuit Learn function takes approximately 20 seconds to run. It allows the unit to ’learn’ what pressure it needs to build in to its calculations, based on the components in the system. Select LEARN CIRCUIT every time you add or remove a component (eg, mask, humidifier) or move to a significantly different altitude. To run this function: 1. Set up the entire VPAP Adapt SV system (flow generator, mask, humidifier etc) as you wish to use it. 2. Make sure that the mask is unobstructed so air can flow from the mask to the flow generator. 3. Turn on the VPAP Adapt SV at the power switch. 4. Move through the menus until you reach LEARN CIRCUIT and select ’yes’ by pressing the Left key. 5. A message will remind you to check that the airflow from the mask is clear. Select ’start’ with the Left key. 6. A progress screen is displayed while the Air Circuit Learn function is running. LEARNING CIRCUIT

Using the VPAP Adapt SV

21