Sleep Lab Titration Guide

Introduction

What is the VPAP Tx Lab System?

VPAP Tx Lab System

Overnight success
A complete comfort experience for fewer disruptions throughout the night
ResMeds revolutionary sleep lab titration system was designed with the patients comfort in mind. A truly all-in-one lab system, the VPAP Tx delivers comfortable therapy and caters to all patient types, allowing them to fall asleep and stay asleep, so your titrations are an overnight success.

Patient Comfort Features

Flexible All-in-One Device Contains all ResMed therapy Easy-Breathe Waveform Synchronizes pressure with

modes for every patient type

Guided Mode Transitions Eliminate sudden changes in

the patients natural breathing pattern

Whisper-Quiet Operation Makes it the quietest all-in-

pressure and enable a smooth transition from one mode or pressure to another

one lab system on the market

VPAP Tx Therapy Device

EasyCare Tx Software

Tx Link

System Components
VPAP Tx Therapy Device A flexible, all-in-one device makes adjustments to Tx Link Provides connectivity between the software and

therapy seamless, simplifying the titration process

EasyCare Tx Software On-screen remote control of the therapy device Displays real-time data from the therapy device Creates summary reports and prescriptions

therapy device
Relays real-time signals measured by the therapy

device to the polysomnography (PSG) equipment

ResMeds VPAP Tx lab system delivers efficient, consistent results

With a spectrum of tools and features, the VPAP Tx helps you introduce a smooth start to your patients therapy, during and after titration. In addition, you can easily make and document changes to therapy, communicate recommendations and upgrade to ResMeds latest enhancements.

Sleep Lab Efficiency Features

Mask Fit Feature Displays real-time leak when fitting Customizable Default Settings Enables customization

the mask at the bedside and ensures the selected mask has a proper seal before starting therapy
Prescription Report Seamlessly incorporates the final

of therapy settings according to your lab protocols

Easy Upgrades Allows you to download new

technologies and features as they are released

Intuitive Software Reduces training time

mask, device and titration settings into a script

Detailed Settings Report Captures all device mode

and pressure changes into an easy-to-read format

True Leak Reporting Automatically displays accurate

mask leak data, eliminating the need to reference charts to calculate appropriate leak values

Detailed Settings Report Prescription Report

VPAP Tx delivers all ResMed therapy modes and clinically superior algorithms
CPAP Fixed pressure delivered with optional T (Timed) The fixed respiratory rate and the fixed

expiratory pressure relief (EPR)

AutoSet Automatically adjusts pressure in response

inspiration/expiration time set by the clinician are supplied regardless of patient effort
VAuto Automatically adjusts pressure in response to

to snore, flow limitation and obstructive sleep apneas with no pressure support
Bilevel Delivers two treatment pressuresone for

inspiration (IPAP) and one for expiration (EPAP)and provides control over the following bilevel therapy modes:
S (Spontaneous) Follows the patients natural

flow limitation, snore and apneas; pressure support (PS) is fixed throughout the night and can be set by the clinician
Adaptive Servo-Ventilation Treats central sleep apnea

(CSA) and/or mixed apneas and periodic breathing

breathing pattern, allowing them to breathe at their regular respiratory rate and rhythm
S/T (Spontaneous/Timed) Augments any breaths

initiated by the patient, but will also supply additional breaths if the breath rate falls below the clinicians set backup respiratory rate

TEChniCaL SPECiFiCaTionS
Pressure Ranges CPAP: 420 cm H2O (EPR 0-3) AutoSet: APAP 420 cm H2O (EPR 0-3) Bilevel (S, S/T, T): EPAP 325 cm H2O IPAP 430 cm H2O VAuto: EPAP 425 cm H2O IPAP 425 cm H2O ASV: Pressure Support 316 cm H2O EEP 415 cm H2O Dimensions 5.6 (l) x 9.8 (w) x 11.5 (h) 14.2 cm (l) x 24.8 (w) x 29.3 cm (h) Weight 8.4 lbs (3.7 kg) Filter Two-layered, powder-bonded, polyester non-woven fiber altitude Compensation Automatic Electrical Requirements 100240 V DC Power Direct connect cord
*EPR available in CPAP and AutoSet modes

EaSyCaRE TX SoFTWaRE
minimum hardware and Software Requirements PC (Mac not supported) Pentium 1 Ghz CPU 1 GB RAM 1024 x 768 display resolution 10/100 Mbps Ethernet Port Microsoft Windows 2000 SP4 or Windows XP SP2 or Windows Vista Microsoft .NET Framework 2.0 Cat 5 cable or available network port between patient room and control room

PaRT numbERS anD aCCESSoRiES

Product name Tx Link and EasyCare VPAP Tx HumidAire 2i Filters (3-Pack) Product Code 25101 25102 30902 26926

Getting Started

VPAP Tx Control Panel

The control panel includes an LCD display, a keypad and alarm LEDs.

VPAP Tx
1
Home

2 4 6 8

3 5 7

1 2

Home Alarm LED

Returns to Ready screen from anywhere in the menu except during power-up, Learn Circuit and Mask Fit. The yellow or red LED illuminates if an alarm is triggered. A message will also appear on the LCD. Performs the function indicated by text displayed above it (eg, entering sub-menus, applying settings and initiating actions). Performs function indicated by text displayed above it (eg, exiting sub-menus and cancelling actions). Increases settings options and scrolls through the menu.

Left

Right

Up

Down

Decreases settings options and scrolls through the menu.

Start/ Stop

Starts or stops treatment. Extended hold for at least two seconds starts the Mask Fit function. The Start/Stop key is backlit continuously. Mutes an audible, active alarm. The mute key backlight will flash when an audible alarm is triggered. This backlight will stay on while the alarm is active but muted.

Alarm Mute

The LCD is backlit whenever any key is pressed. The lighting turns off Automatically if no key is pressed for two minutes.

Mask Type
Checking and changing the mask type
The mask type should be checked when the VPAP Tx is turned on or a mask is connected to the air tubing. To ensure accurate prescriptions, ResMed mask systems are ideal for use with this therapy device.

To change the mask type:

1. From the Ready screen press the Left key. The Setup Menu will appear. 2. Press the Left key. The Mask screen will appear. 3. Check the displayed mask type is correct. If correct, press the Home key to exit and return to the Ready screen. If incorrect, press the Left key to change the mask type. 4. Press the Up or Down keys until you reach the correct mask. 5. Press the Left key to select the Mask. 6. Press the Home key to exit and return to the Ready screen. CAUTION

The mask selection should be changed whenever the mask type is changed to a new group (ie, pillows, full face or nasal).

Mask Fit
Optimizing mask fit
The VPAP Tx mask-fitting feature delivers air pressure for checking and adjusting mask fit to minimize leaks.

To optimize mask fit:

1. Fit the mask as instructed in the mask user guide. 2. Hold down the Start/Stop key for more than two seconds. The VPAP Tx will start to deliver pressure at 10 cm H3O and the Mask Fit screen will appear.
Mask Fit: ***** Leak (L/min) mm.m

The LCD displays a Mask Fit star rating from zero to five stars. Three to five stars indicates a good fit or better. Zero or two stars indicates that the mask needs to be adjusted.
3. Adjust the mask, cushion and headgear to achieve optimal fit. After three minutes, treatment will begin. If you do not wish to wait three minutes, hold down the Start/Stop key for three seconds and treatment will begin immediately.

10

Therapy Screen Display

Therapy screens
During therapy, the VPAP Tx LCD will display information about the current therapy mode. The following examples show the type of information that may be displayed. Press the Home key to return to the Ready screen. The Therapy screen will be restored after two minutes without a key being pressed.

Example 1: Therapy set to CPAP mode

Where: pp.p X mm.m is the set pressure indicates the level of pressure relief is the unintentional leak value

CPAP pp.p Leak (L/min)

EPR x mm.m

Example 2: Therapy set to VAuto mode

Where: ee.e jj.i mm.m

VAUTO Leak (L/min)

ee.e-ii.i mm.m

is the EPAP value for the current breath as determined by the algorithm is the IPAP value for the current breath as determined by the algorithm is the unintentional leak value

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VPAP Tx Menus
Navigating the VPAP Tx menus
The VPAP Tx provides a set of functions which are arranged in menus and submenus. These functions are viewed on the LCD screen. Many of these functions are also accessible remotely by EasyCare Tx. The menus provided are outlined in the following table.
Setup Therapy Data Select mask and perform Learn Circuit Adjust therapy modes and settings. Refer to the EasyCare Tx Online Help for details. Access real-time measures of system leak, mask pressure, patient flow and ventilatory parameters. These figures are updated at least once every breath. The best place to view this data is via EasyCare Tx. Advanced Service Save a set of preferred default settings and restore these settings if required. Also, adjust user preferences such as language and data units. Access information about the VPAP Tx, including software version, serial number and run hours.

To navigate and make selections within the menus:

1. From the Ready screen, press the Left key to view the menu items. 2. Press the Up and Down keys until you reach the relevant menu. 3. Press the Left key to enter the menu. 4. Press the Up and Down keys to look through the available sub-menus. 5. Press the Left key to select a sub-menu. 6. Press the Up and Down keys to change the option. 7. Press the Left key to apply the option. 8. Press the Home key to exit and return to the Ready screen.

Starting a Session
Before you start titrating a patient, you need to start EasyCare Tx and then start a titration session.
To start a titration session:
1. Double-click the EasyCare Tx icon on the Desktop. The EasyCare Tx toolbar is displayed and the default Tx Link is automatically connected. If the Tx Link is not automatically connected, connect to a Tx Link. 2. Configure Mask and Humidifier Settings. 3. Click the Therapy Start/Stop icon. Titration begins and the therapy indicator turns green. Note: The Therapy ON/OFF indicator turns green during therapy and grey when therapy is off.

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Manual Connection to a Tx Link

Connecting to a Tx Link
If you do not specify a default Tx Link in User Preferences, the following window is displayed every time you launch EasyCare Tx. From this window you can connect to any Tx Link on the network.

To connect to Tx Link:
1. From the Menu drop-down, click Connect. The Select Device window is displayed. 2. Select the required Tx Link from the Connect To drop-down list. 3. Click OK. A window indicating that EasyCare Tx is establishing a connection with Tx Link is displayed.

Bed 1 - EasyCare Tx

Within a few seconds, EasyCare Tx will connect to the Tx Link.

Connectivity issues
You may experience connectivity issues in the following circumstances:
EasyCare Tx is unable to connect to the Tx Link EasyCare Tx loses connectivity with the Tx Link Tx Link is unable to connect to the therapy device Tx Link loses connectivity with the therapy device.

In such instances, a window indicating the connectivity status is displayed and this helps you to take the appropriate action to restore connectivity. For instructions on resolving these issues, refer to troubleshooting.

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EasyCare Tx Toolbar Overview

EasyCare Tx is designed as a user-friendly toolbar and allows remote control of a therapy device while displaying current therapy settings.

1 2 3 4 5 6 7 8 9 10 11 12

Name of the connected Tx Link Therapy controls Therapy controls drop-down Real-time data Real-time data items drop-down Start/Stop Therapy button Therapy device connected Therapy ON/OFF indicator Humidifier ON/OFF indicator1 Menu drop-down Therapy mode drop-down Locked/unlocked status

The Humidifier icon is only displayed if the connected therapy device has a humidifier that can be remotely controlled.

14

Configuring Mask and Humidifier Settings

Configuring circuit settings
Before starting therapy, select the mask type used by the patient and review the humidifier settings.
Mask Settings Mask Settings can be specified either at the bedside from the therapy device, or remotely using EasyCare Tx. Humidifier Settings EasyCare Tx automatically provides humidifier controls relevant to the therapy device and type of humidifier connected. Some humidifiers are not controllable. Others can be disabled (for cold passover), or enabled (and adjusted using the dial on the humidifier). Still others can be adjusted remotely to a specific humidity level or to a climate controlled temperature. Refer to the Clinical guides provided with the therapy device and humidifier.

To configure circuit settings:

1. From the Menu drop-down, click Mask & Humidifier Settings. The Mask and Humidifier Settings window is displayed. 2. Select the required mask type from the Mask drop-down list. 3. Select the desired humidifier option from the Humidifier drop-down list, or the desired temperature setting from the Temperature drop-down list. 4. Click OK. The mask and humidifier settings are applied to EasyCare Tx.

Therapy settings

Adjusting Therapy Settings

Therapy settings can be controlled in two ways:

by adjusting individual parameters displayed on the toolbar using the Therapy Settings window.

When adjusting individual parameters displayed on the toolbar, the changes are applied instantly. If a confirmation is not sent from the therapy device within two seconds, the parameter will revert the original value. Alternatively, using the therapy settings window, changes are made to one or more parameters related to a therapy and on pressing OK.

To adjust therapy settings from the Therapy Settings window:

1. From the Menu drop-down, select Therapy Settings. The current therapy settings window is displayed. 2. Change the appropriate therapy settings as required. 3. Click Apply.

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Titration Protocols

CPAP Titration Protocol

Set mode to CPAP Initial pressure: 45 cm H2O
* Note: A higher pressure may be required for re-titrations, patients with a higher BMI or patients complaining of air hunger or suffocating sensations ** For re-titrations, it is recommended that the pressure be started 23 cm H2O below the patients current pressure

EPR comfort setting Set to patient comfort (1, 2 or 3)

Monitor patient

Yes

Is the patient having obstructive events?

No

Increase CPAP 1 cm H2O every 5 mins for obstructive apneas, hypopneas, RERAs and at least 3 min of loud or unambiguous snoring
Yes

Are events central?

Continue monitoring patient Decrease CPAP by 1 cm H2O and wait 20 mins. Consider Adapt SV if centrals persist and patient meets criteria
No

Consider trial of bilevel if obstructive events persist at a pressure of 15 cm H2O

Observe patient and document final settings; be sure to document the final CPAP pressure, EPR setting (if any) and ramp time
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CPAP Prescription:
q S9 Elite w/ Climate Control q S8 Elite ii q S8 Escape ii
q EPR: 1 2 Ramp Time: Interface: 3 min(s) (OFF - 45 min)

Sample

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EPR and Easy-Breathe (CPAP and AutoSet)

EPR is designed to maintain optimal treatment for the patient during inhalation and reduce the delivered mask pressure during exhalation in the CPAP or AutoSet mode. The desired result of EPR is to decrease the pressure the patient must breathe out against, making the overall therapy more comfortable.

The EPR features:

Automatically disabled in the event of an apnea. Resumes automatically when the apnea event has passed. EPR LEVEL of OFF 1, 2, or 3 cm H2O can be selected , In CPAP mode, the EPR INHALE can be set to medium or fast. Pressure drop is limited to avoid sub optimal treatment (maximum drop is 3 cm H2O). When enabled, the delivered pressure will not drop below a minimum pressure of 4 cm H2O, regardless of the settings. EPR ACCESS allows the clinician to enable or disable patient access to the EPR level setting.

The graph illustrates the effect of EPR inhalation settings with Easy-Breathe.

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EPR
Comfort levels
EPR provides three comfort settings. Each comfort setting correlates to an exact drop in pressure relief: Setting 1: Mild reduction (1 cm H2O) Setting 2: Medium reduction (2 cm H2O) Setting 3: Maximum reduction (3 cm H2O).

Note: The numeric value (1, 2 or 3 cm H2O) for each EPR setting represents the maximum pressure drop during CPAP therapy expiration. Therapy pressure will never drop below 4 cm H2O. So, for example, if therapy pressure during Ramp Time is 5 cm H2O and EPR is set at level 3, then the pressure will only reduce to 4 cm H2O. For this reason, EPR is a unique comfort feature that ensures therapy effectiveness at all times. EPR allows patient comfort without compromise because the selected setting offers a defined pressure drop value that never exceeds the setting value.

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Titration for VPAP S Therapy

(bilevel spontaneous)
Indications for VPAP S
CPAP intolerance Continued obstructive events at higher pressures Hypoventilation with SpO2 < 90% COPD

Has patient been on CPAP therapy?

Yes No

Set VPAP pressure to:

IPAP = CPAP settings EPAP = 4 cm H2O below IPAP setting

Set VPAP pressure to:

IPAP = 8 cm H2O EPAP = 4 cm H2O

For obstructive apneas:

Increase EPAP by 1 cm H2O every 5 min. Increase IPAP to maintain 4 cm H2O difference between IPAP/EPAP

Are events central?

For obstructive hypopneas and snoring:

Increase IPAP 1 cm H2O every 5 min until resolved

Yes

No

Decrease pressure to previous setting, observe for 20 min

For SPO2 < 90% with all respiratory events eliminated:

Increase IPAP by 1 cm H20 every 15 min until 90% SpO2 is reached Follow sleep lab protocols for adding O2

If centrals persist, consider ASV

Observe patient and document final settings, including IPAP/EPAP pressures and TiControl settings if altered from default
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VPAP S Prescription:
q VPaP S
q IPAP: cm H2O (4-25 cm H2O) EPAP: cm H2O (3-25 cm H2O) Ramp Time: min(s) (OFF - 45 min) Interface:

Sample

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Proven technology, effective treatment

ResMeds VPAP technologies ensure comfortable therapy and enable the clinician to fine-tune settings to a degree not possible in competitive products.

Cycle sensitivity settings Leak onset

New base flow

Base flow Patient flow Vsync responds

Patient Flow Trigger sensitivity settings EPAP

TiControl for maximum control and customized therapy

TiControl provides minimum and maximum inspiratory time limits. These frame a window of opportunity to accommodate individual respiratory conditions. For example, TiControl is clinician-adjustable to customize therapy for chronic obstructive pulmonary disease (COPD) patients and can prolong Ti Min for patients with restrictive disorders.

Adjustable trigger & cycle sensitivities

Because every patient is different, five sensitivity settings provide the clinician with more opportunities to fine-tune therapy.

Vsync for reliable pressure delivery

Ti Max IPAP

Ti Min
Cycle Window

Unique to the VPAP series, Vsync manages leaks automatically, minimizing any loss of pressure due to leak while still ensuring reliable breath detection.

Rise time

Backup rate, S/T and T Modes (VPAP ST only)

For the treatment of neuromuscular and restrictive thoracic diseases, VPAP ST provides a programmable backup rate in S/T and T modes. Now even your noninvasive ventilation patients can benefit from Easy-Breathe quiet performance and a sleek, travel-friendly package.

EPAP Breathe cycle (BPM) 0

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Triggering and Cycling (S, ST and VAuto modes)

The therapy device triggers (initiates IPAP) and cycles (terminates IPAP and changes to EPAP) as it senses the change in patient flow in S, ST or VAuto mode. By adjusting triggering and cycling sensitivity levels, breath synchronization is achieved across a broad range of patient conditions.

Once adjusted, triggering and cycling levels are maintained by the automatic leak compensation feature Vsync. Unique to ResMed, the Vsync algorithm automatically adjusts for leak as it occurs. This provides accurate reporting of patient flow and ensures optimum synchronization and patient support.

26

Triggering and Cycling

Setting Ti Max and Ti Min using the respiratory rate table
1. 2. 3. 4. Instruct the patient to breathe normally while comfortably sitting or lying down. Count the patients respiratory rate (breaths/minute). Considering the patients respiratory disease, refer to the appropriate range of settings in the table below (restrictive, COPD or normal) to set Ti Max and Ti Min. In the case of COPD or normal lungs, use the Ti Min default setting.

ResMed TiControl: Ti Min and Ti Max Calculation Guide

Respiratory Frequency
(BPM)

Restrictive Ti Max Ti Min

COPD Ti Max

Normal Ti Max

30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12

1.0 1.0 1.1 1.1 1.2 1.2 1.3 1.3 1.4 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.3 2.5

0.5 0.5 0.5 0.6 0.6 0.6 0.6 0.7 0.7 0.7 0.8 0.8 0.8 0.9 0.9 1.0 1.1 1.2 1.3

0.7 0.7 0.7 0.7 0.8 0.8 0.8 0.9 0.9 0.9 1.0 1.0 1.1 1.2 1.2 1.3 1.4 1.5 1.7

1.0 1.0 1.1 1.1 1.2 1.2 1.3 1.3 1.4 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.3 2.5

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Restrictive Lung Disorders

Some patients with obstructive sleep apnea (OSA) and restrictive respiratory disorders have problems with early or premature cycling to expiration. This will cause inspiratory time to be too short and could affect the patients ability to have an adequate tidal volume, resulting in hypoventilation. A safety system, Ti Min, has been added to the VPAP to prevent premature or early cycling. Late cycling is not a common problem in this patient population however, high leak conditions can interfere with cycling to expiration and eventually cause poor patientventilator synchrony. A safety system, Ti Max, has been added to the VPAP to prevent late cycling.

Setting Ti Min
1. Measure the respiratory rate (see instructions below). 2. Refer to the table column entitled Restrictive Ti Min. 3. Set Ti Min to the value that corresponds to the resting respiratory rate from step 1. 4. If the patient complains that the inspiratory time is too long or too short, verify the respiratory rate and Ti Min setting or adjust the Ti Min setting until the patient feels the inspiratory time is slightly too long. 5. Reduce the Ti Min setting by 0.2 to 0.3 seconds from the setting in the previous step.

Setting Ti Max
1. Measure the respiratory rate (see instructions below). 2. Refer to the table column entitled Restrictive Ti Max. 3. Set Ti Max to the value that corresponds to the resting respiratory rate from step 1. 4. If the patient complains that inspiratory time is too short, verify the respiratory rate and Ti Max setting.

Obstructive Pulmonary Disease

Patients with OSA and COPD typically require a longer expiratory time to avoid or minimize air-trapping. Failure to cycle to expiration can occur due to high airway resistance and/or a high leak condition. This could increase inspiratory time and cause further air-trapping, interfere with cycling and eventually cause poor patientventilator synchrony. A safety system, Ti Max, has been added to the VPAP to prevent late cycling.

Setting Ti Max
1. Measure the respiratory rate (see instructions below). 2. Refer to the table column entitled COPD Ti Max. 3. Set Ti Max to the value that corresponds to the resting respiratory rate from step 1. 4. If the patient complains that the inspiratory time is too short, verify the respiratory rate and Ti Max setting.

Setting Ti Min
Most patients with OSA and COPD do not have problems with premature cycling, therefore the Ti Min setting can remain at the default setting of 0.3 seconds.

Normal Pulmonary Systems

Nasal mask therapy is often associated with mouth leaks that can lead to prolonged inspiratory time due to late cycling. This can cause patient ventilator dysnchrony, sleep disruption, noncompliance and other complications. A safety system, Ti Max, has been added to the VPAP to prevent late cycling.

Setting Ti Max
1. Measure the respiratory rate (see instructions below). 2. Refer to the table column entitled Normal Ti Max. 3. Set Ti Max to the value that corresponds to the resting respiratory rate from step 1. 4. If the patient complains that the inspiratory time is too short, verify the respiratory rate and Ti Max setting.

Setting Ti Min
Most patients with OSA do not have problems with premature cycling, therefore the Ti Min setting can remain at the default setting of 0.3 seconds.

Measuring Respiratory Rate: Measure the patients resting respiratory rate during assisted ventilation. If you think the patients respiratory rate will decrease during sleep and you are unable to measure it, then estimate the nocturnal respiratory rate and use this figure to determine the Ti Max and Ti Min setting. Refer to the section above that most appropriately matches the patients condition. In some instances, recommended settings may need to be fine-tuned based on patient feedback and/or ongoing clinical assessment.

note: If a high leak condition is noted (leak 24 L/min) the nasal mask fitting should be adjusted, and/or a Mirage Quattro Full Face Mask used in the event of a mouth leak.

28

Titration for VPAP ST Therapy

(bilevel spontaneous, timed)

Set VPAP pressure to:

IPAP = 8 cm H2O settings EPAP = 4 cm H2O Set back up rate at 2-4 below resting respiratory rate

Indications for VPAP ST therapy

Neuromuscular disorders Restrictive disorders Obesity hypoventilation

For obstructive apneas:

Increase EPAP by 1 cm H2O every 5 min Increase IPAP to maintain 4 cm H2O difference between IPAP/EPAP

For residual snoring, hypopneas and/or O2 desats

Increase IPAP 1 cm H2O every 5 min until resolved

For SPO2 <90% with all respiratory events eliminated:

Increase IPAP by >1 cm H2O every >15 min until SpO2 >90% is reached Follow sleep lab protocol for adding O2

Evaluate VT (tidal volume) If too small:

Maintain EPAP raise IPAP by 1 cm H2O every 15 min until SpO2 90% * Exploratory pressure increase should not exceed 5 cm H2O

Evaluate if backup rate is adequate:

Increase backup rate 1-2 BPM every 20 min as needed

Observe patient and document final pressure settings (IPAP/EPAP pressures, respiratory rate and TiControl settings) if altered from default

29

VPAP ST Prescription:
q VPaP ST
q Spont Mode q Spont/Timed Mode IPAP: cm H2O (4-25 cm H2O) for VPAP ST EPAP: cm H2O (3-25 cm H2O) Rate: BPM (5-30 BPM) Ramp Time: min(s) (OFF - 45 min) Interface:

Sample

30

VPAP Adapt SV Titration

The treatment for CSA, mixed apnea and periodic breathing.

Start therapy at default settings and observe patient for 20-40 minutes Throughout titration adjust mask as needed to maintain leak less than 24 L/min

Is patient having events?

No

Yes

No

Are events obstructive?

Yes

Increase EEP by 1 cm H2O every 20 minutes until obstructive events are eliminated

Are there residual events?

Observe patient. Document response to therapy.

Increase Min PS by 1 cm H2O every 20 minutes until events are eliminated

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Note:

Before making changes, always verify leak is below 24 L/min. After changing a setting, always wait 20 minutes before making another change.

If patient exhibits:
Obstructive events Residual events: Snoring Respiratory arousals Desaturations Flow limitation

Try the following:

Increase EEP by 1 cm H2O Increase Min PS by 1 cm H2O

ICD-9
327.21 327.22 327.26 327.27 Primary CSA* High altitude periodic breathing Sleep-related hypoventilation/hypoxemia in conditions classifiable elsewhere (requires underlying diagnosis code) CSA in conditions classified elsewhere (requires underlying diagnosis code) 786.04 CSA due to CheyneStokes respiration (CSR)
*Most commonly used for complex sleep apnea patients. These are examples of diagnoses that may be associated with the above mentioned technology. Physicians must determine the appropriate ICD-9 diagnosis based on individual patient needs during the initial exam or through a history and physical.

After hours support available MondayFriday 6pm3am (PT) by calling 1-888-AUTOSET (1-888-288-6738)

32

VPAP Adapt SV and Adaptive Servo-Ventilation

Airflow

APNEA
VPAP Adapt SV
VPAP Adapt SV

VPAP Adapt SV and adaptive servo-ventilation With its advanced adaptive servo-ventilation algorithm, the ResMed VPAP Adapt SV provides ventilatory support to rapidly treat all forms of CSA, mixed apnea and periodic breathing, commonly known as CheyneStokes respiration (CSR). The adaptive servo-ventilation algorithm delivers customized therapy Ventilation to a moving target To determine the degree of pressure support needed, the adaptive servo-ventilation algorithm continuously calculates a target ventilation. Based on respiratory rate and tidal volume, the target is 90% of the patients recent average ventilationthat means that ventilation can vary gradually and naturally over the course of the night. Patientmachine synchronization The algorithm uses three factors to achieve synchronization between pressure support and the patients breathing. 1. The patients own recent average respiratory rate, including the ratio of inspiration to expiration and the length of any expiratory pause. 2. The instantaneous direction, magnitude and rate of change of the patients airflow, which are measured at a series of set points during each breath. 3. A backup respiratory rate of 15 breaths per minute.
Late mid-inspiration Early end-inspiration

Airflow

Time

To ensure ventilatory support is synchronized to the patients effort, the VPAP Adapt SV relies on factors 1 and 2. When a central apnea or hypopnea occurs, support initially continues to reflect the patients recent breathing pattern. However, as the apnea/ hypopnea persists, the device increasingly uses the backup respiratory rate. Minimal support during stable breathing The adaptive servo-ventilation algorithm starts working even before CSA events occur, from the moment the patient lies down, puts on the mask and switches on the VPAP Adapt SV. As long as ventilation is at or above the target: The magnitude of the pressure support remains minimal, the default minimum value of 3 cm H2O provides enough support to do about half the work of breathing.

33

Reduction in respiratory effort

Pressure (cm H2O)

MAX PS= 11 cm H2O } MIN PS= 3 cm H2O EEP= 4 cm H2O

Patient Respiratory Flow Time

Normal breathing effort Central apnea/hypopnea (no spontaneous effort)

The underlying end expiration pressure (EEP) can be adjusted by the clinician from 4 to 15 cm H2O, which helps reduce obstructive events and can also reduce central events. Support when its needed When a central hypopnea or apnea occurs and ventilation suddenly drops below the target: Pressure support rapidly increases over a few breaths to keep ventilation at the target. The default maximum pressure support value of 15 cm H2O will fully ventilate a centrally apneic patient with an open airway and normal lungs. Adaptive support when breathing resumes As breathing resumes and total ventilation exceeds the target: the minimum 3 cm H2O.

Why adaptive servo-ventilation instead of bilevel? Most CSA/CSR patients have trouble tolerating conventional bilevel ventilatory support. The pressure must be adjusted to a constant high level to adequately support a patient during apnea/hypopnea. This leads to over-ventilation during periods of normal breathing or hyperpnea, which causes arousals and discomfort. It can even propagate more CSA events. The adaptive servo-ventilation algorithm stabilizes patient breathing By ventilating the patient appropriately during periods of hypopnea and apnea and reducing support during periods of hyperventilation and normal breathing, the advanced adaptive servo-ventilation algorithm rapidly stabilizes breathing patterns and arterial blood gases and minimizes the discomfort and arousals often associated with bilevel treatment.

Pressure support is rapidly reduced back toward

This reduces the likelihood of over-ventilation and

hypocapnia, which can lead to vocal cord closure and further apneas.

34

EEP and Pressure Support (ASV mode)

End expiratory pressure (EEP) can be adjusted to maintain upper airway patency in ASV mode. Pressure Support (PS) is defined as the difference between the peak pressure at the end of inspiration, and the minimum pressure at the end of expiration (ie, the amplitude of the pressure waveform delivered). The pressure support (Inspiration: Expiration and Expiration: Inspiration) trigger points are set automatically based on measurement of the patient respiratory flow. ASV mode automatically adjusts pressure support between Max PS and Min PS to keep the patients respiratory flow even. ResMed recommends minimum pressure support to be set to 3 cm and maximum pressure support to be greater than or equal to 10 cm.

35

Reimbursement

VPAP Adapt SV Reimbursement Coding

MD Primary care physician
ICD-9 Codes
Sleep-related breathing disorders, hypersomnias, circadian rhythm sleep disorders, parasomnias, sleep-related movement disorders (a listing of ICD-9 codes related to sleep disorders can be found in the ResMed Reimbursement Manual) EXAMPLE: 780.54 Hypersomnia, unspecified *It is important to note that Medicare will not recognize all codes as medically necessary for sleep disorder testing. Medicare most commonly accepts diagnoses of sleep-related breathing disorders, narcolepsy, parasomnias and impotence.

MD sleep specialist
ICD-9 Codes
327.21 Primary CSA* 327 .22 CSA due to high altitude periodic breathing 327 .26 Sleep-related hypoventilation/hypoxemia in conditions classifiable elsewhere (requires underlying diagnosis code) 327 .27 CSA in conditions classified elsewhere (requires underlying diagnosis code) 786.04 CSA due to CSR
* Most commonly used for complex sleep apnea patients. These are examples of diagnoses that may be associated with the above mentioned technology. Physicians must determine the appropriate ICD-9 diagnosis based on individual patient needs during the initial exam or through a history and physical.

CPT Codes
95810 PSG; sleep staging with four or more additional parameters of sleep, attended by a technologist 95811 PSG; sleep staging with four or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist (94770 carbon dioxide, expired gas determination by infrared analyzer)

CPT is a trademark of the American Medical Association

Definitions
Respiratory Insufficiency Impairment in respiratory function severe enough to prohibit certain activities that the patient might normally pursue, and to interfere with daily living; occurring in association with measurements of respiratory mechanics and/or gas exchange that are markedly abnormal. Complex sleep apnea (CompSA) is a form of CSA specifically identified by the persistence or emergence of central apneas or hypopneas upon exposure to CPAP or an E0470 device when obstructive events have disappeared. These patients have predominantly obstructive or mixed apneas during the diagnostic sleep study occurring at greater than or equal to five times per hour. With use of a CPAP or E0470, they show a pattern of apneas and hypopneas that meets the definition of CSA. CSA is defined as: (1) An apneahypopnea index greater than five; and (2) Central apneas/hypopneas greater than 50% of the total apneas/hypopneas; and (3) Central apneas or hypopneas greater than or equal to five times per hour; and (4) Symptoms of either excessive sleepiness or disrupted sleep.1

Prescription for VPAP Adapt SV

HCPCS Code E0471 Bilevel w/ backup rate

References 1 Centers for Medicare & Medicaid Services, LCD for Respiratory Assist Devices (L11493) U.S. Department of Health and Human Services, http://www.cms.hhs.gov/mcd/viewlcd. asp?lcd_id=11493&lcd_version=22&show=all (revision effective date 4/01/2006) Current Procedural Terminology 2005 American Medical Association. All Rights Reserved. Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

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Medicare Policy for Treatment of OSA

CPAP qualifications (E0601)
Patient must meet all the following criteria to qualify for an E0601 device (CPAP such as S9 Series) , Patient has had a face-to-face clinical evaluation* by treating physician prior to sleep test. Patient has had a Medicare-covered sleep test** that meets either of the following criteria: a. AHI/RDI is 15 events per hour with minimum of 30 events; OR b. AHI/RDI is 5 and 14 events per hour with minimum of 10 events and documentation of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke Diagnosed with OSA (ICD-9 code of 327 .23) Patient and/or caregiver has received instruction from the supplier of the CPAP device and accessories in the proper use and care of the equipment.
* Face-to-face clinical evaluation may include sleep history and symptoms of OSA, Epworth Sleepiness Scale and physical exam documenting body mass index, neck circumference and a focused cardiopulmonary and upper airway evaluation. Some of these elements, in addition to other details, must be documented in patient charts. ** medicare-covered sleep tests include Type I, Type II, Type III and Type IV (must monitor and record a minimum of three (3) channels). All sleep tests must be interpreted by a physician who is boardcertified in sleep medicine by the ABSM, board-certified in sleep medicine by member board of ABMS, trained in an ABMS member board specialty and is awaiting exam, or active staff member of an AASM or The Joint Commission accredited sleep center or lab. (Effective 11/1/08 for Home Sleep Testing and 1/1/10 for Polysomnography)

Bilevel qualifications (E0470)

(Follow for CPAP to bilevel conversion) Patient must meet all the following criteria to qualify for an E0470 device (bilevel without a backup rate, such as VPAP Auto 25) Patient is qualified for E0601 (CPAP). CPAP has been tried and proven ineffective based on a therapeutic trial conducted in a facility or a home setting.Treating physician must document: Beneficiary tried but was unsuccessful with attempts to use E060 Multiple interface options have been tried and the current interface is most comfortable Work of exhalation with current pressure setting of E0601prevents beneficiary from tolerating the therapy; and, Lower pressure settings of E0601 fail to adequately control the symptoms of OSA or reduce AHI/RDI to acceptable levels. Yes No Has CPAP been used < 3 months (ie, CPAP is tried and found ineffective during the initial 3-month home trial)?

If No, a new initial face-to-face clinical evaluation is required but not a new sleep test. A new 3-month trial would begin for use of the bilevel. If Yes, the patient is qualified for an E0470 device (bilevel without a backup rate, such as VPAP Auto 25)

Documentation for continued coverage

(for continuing to bill months 4-13) Between 31st and 91st day, treating physician has a face-to-face clinical re-evaluation with patient documenting that symptoms of OSA improved. Objective evidence of adherence to use of the PAP device reviewed by treating physician. Adherence is use of PAP 4 hours per night on 70% of nights during a consecutive 30-day period any time during the first 3 months of initial usage. Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data.
RDi is defined as the average number of apneas plus hypopneas per hour of recording.

ahi is defined as the average number of episodes of apnea and hypopnea per hour of sleep.

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Respiratory Assist Device (RAD) Qualifying Guidelines

CMS guidelines February 2010

i. Restrictive thoracic disorders

Documentation of neuromuscular disease or severe thoracic cage abnormality

ii. CoPD
ABGs (done while awake) PaCO2 52 mm Hg (patients prescribed FiO2)

Perform one of the following:

ABGs (done while awake) PaCO2 45 mm Hg (patients prescribed FiO2) or Sleep oximetry Oxygen saturation 88% for 5 minutes, minimum 2 hours recording time (patients prescribed FiO2) or For neuromuscular disease only, either FVC < 50% of predicted or MIP < 60 cm H2O

Sleep oximetry Oxygen saturation 88% for 5 minutes, minimum 2 hours recording time (on 2 L/min O2 or patients prescribed FiO2, whichever is higher)

OSA and CPAP treatment has been considered and ruled out

(E0470)
For CoPD patients to qualify for a RaD with backup rate (E0471):

COPD does not contribute significantly to pulmonary limitation

Situation 1 After period of initial use of an E0470, ABG (done while awake) shows PaCO2 worsens 7 mm Hg compared to original ABG result (on patients prescribed FiO2); PSG demonstrates oxygen saturation 88% for 5 minutes, minimum 2 hours recording time, on an E0470, not caused by obstructive upper airway events (ie, AHI < 5). Situation 2 No sooner than 61 days after initial use of E0470, ABG (done while awake) shows PaCO2 52 mm Hg (on patients prescribed FiO2); Sleep oximetry on an E0470 demonstrates oxygen saturation 88% for 5 minutes, minimum 2 hours recording time (on 2 L/min O2 or patients prescribed FiO2, whichever is higher).

(E0470) or (E0471) Based on the treating physicians judgment

Respiratory assist device (RAD) documentation requirements for continued coverage Patients on an E0470 or E0471 device must be re-evaluated no sooner than 61 days after initiating therapy. Required documentation Progress of relevant symptoms Signed and dated statement by treating physician declaring patient using average 4 hours per 24-hour period and patient benefiting from use

ResMed E0470 and E0471 devices E0470Bilevel without a backup rate

VPAP Auto 25 VPAP S

E0471Bilevel with a backup rate

VPAP ST VPAP Adapt SV

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iii. CSa or CompSa

Full PSG, attended in sleep lab

iV. hypoventilation
ABGs (done while Covered by E0470 being used

awake) PaCO2 45 mm Hg
(patients prescribed FiO2)

Dx: CSA or CompSA

Spirometry FEV1/FVC 70% and an FEV1 50% of predicted

Refer to SEVERE COPD category for information about device coverage for patients with FEV1/FVC <70% or FEV1 <50% of predicted

Spirometry FEV1/FVC 70% and an FEV1 50% of predicted

Refer to SEVERE COPD category for information about device coverage for patients with FEV1/FVC <70% or FEV1 <50% of predicted

Improvement of sleep-associated hypoventilation with use of E0470 or E0471 device on:

Settings that will be prescribed for initial use at home Patients prescribed FiO2

ABGs
(done during sleep or immediately upon awakening)

ABGs
(done while awake)

(E0470) or (E0471) Based on the treating physicians judgment

PaCO2 worsened 7 mm Hg compared to original ABG (patients prescribed FiO2) or

PSG demonstrates

PaCO2 worsens 7 mm Hg compared to ABG result used to qualify for E0470 (patients prescribed FiO2) or
PSG demonstrates

A diagnosis of CSA requires all of the following:

1. An apnea hypopnea index > 5 2. Central apneas/hypopneas > 50% of

oxygen saturation 88% for 5 minutes, minimum 2 hours recording time not caused by obstructive upper airway events (ie, AHI < 5)

oxygen saturation 88% for 5 minutes, minimum 2 hours recording time, on E0470, not caused by obstructive upper airway events (ie, AHI < 5)

the total apneas/hypopneas times per hour

3. Central apneas or hypopneas 5 4. Symptoms of either excessive

(E0470)

(E0471)

CompSA is a form of central apnea:

Identified by the persistence or emergence of central apneas or

hypopneas upon exposure to CPAP or an E0470 device when obstructive events have disappeared

CompSA patients have predominantly obstructive or mixed apneas

during the diagnostic sleep study occurring at 5 times per hour and hypopneas that meets the definition of CSA

With use of a CPAP or E0470 device, they show a pattern of apneas

This information is provided as of the date listed, and all coding and reimbursement information is subject to change without notice. It is the providers responsibility to verify coding and coverage with payors directly. For a full description of the policy go to www.cms.hhs.gov. ResMed reimbursement hotline, dial 1-800-424-0737 and select option 4.

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ResMed Corp San Diego, CA, USA +1 858 836 5000 or 1 800 424 0737 (toll free). ResMed Ltd Bella Vista, NSW, Australia +61 (2) 8884 1000 or 1 800 658 189 (toll free). See www.resmed.com for other ResMed locations worldwide. TiControl, VPAP Adapt SV and Vsync are trademarks of ResMed Ltd. AutoSet, EPR, HumidAire, Mirage, Mirage Quattro, S9 and VPAP are trademarks of ResMed Ltd and are registered in the U.S. Patent and Trademark Office. 2010 ResMed. 1013904/1 10 06

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