Respironics 1017226 Sleep Diagnosis System User Manual

The Alice® 5 system is covered by the following patent: U.S. Patent No. 6,425,861.

The information contained in this document is the property of Respironics, Inc. Except as

specifically authorized in writing by Respironics, the holder of this document (1) shall keep all

information contained herein confidential and shall protect same in whole or in part from disclo-

sure and dissemination to all third-parties, and (2) shall use same for operation and maintenance

purposes only.

All information contained in this document is subject to change without notice. Respironics

reserves the right to make changes to equipment design or program components, as progress in

engineering, manufacturing methods, or other circumstances may warrant.

Chapter 1: Introduction...............................................................................................................1-1

1.1 Alice 5 System Contents ...............................................................................................1-2

1.2 Warnings and Cautions ..................................................................................................1-4

1.2.1 Warnings ..............................................................................................................1-4

1.2.2 Cautions ..............................................................................................................1-5

1.3 Intended Use ..................................................................................................................1-6

1.4 Hardware Component Overview ...................................................................................1-7

1.4.1 Data Flow through the Alice 5 Components .......................................................1-7

1.4.2 Alice 5 Base Station ............................................................................................ 1-9

1.6 Acronyms and Definitions .............................................................................................1-18

1.7 Contacting Customer Service ........................................................................................1-21

Chapter 2: Alice 5 Equipment Setup ..........................................................................................2-1

2.1 Before You Begin ..........................................................................................................2-2

2.2 Setting Up Your Network ..............................................................................................2-2

2.2.1 Network Setup Examples .................................................................................... 2-2

2.2.2 Using a Point-to-Point Setup ...............................................................................2-5

2.2.2.1 Map Your Facility’s Network Setup ........................................................2-6

2.2.3 Using a Wired Network Setup ............................................................................2-7

2.2.4 Using an Access Point Infrastructure Network ...................................................2-8

3.2 Adding Alice Devices ....................................................................................................3-6

3.2.1 Adding an Alice 5 Device ...................................................................................3-6

4.2 Patient Setup ..................................................................................................................4-2

4.2.2 Attaching ECG Electrodes ..................................................................................4-6

4.2.3 Attaching Chest and Abdomen Effort Sensors ....................................................4-8

4.3.1 Check Your Cable Connections .......................................................................... 4-11

4.3.2 Check Your Equipment Performance .................................................................. 4-12

4.3.2.1 Check Impedance Using the Alice Sleepware ........................................4-12

4.3.2.2 Check Calibration ................................................................................... 4-13

4.3.3 Starting an Acquisition ........................................................................................4-15

4.2.4 Stopping an Acquisition ......................................................................................4-16

5.2 Base Station Auxiliary Channels ................................................................................... 5-10

5.2.1 Display Properties of Auxiliary Input Channels .................................................5-10

6.1 Base Station, Headbox, and Patient Cable ....................................................................6-1

6.2 Sensors .......................................................................................................................... 6-2

6.2.1 EEG Electrodes ...................................................................................................6-2

6.2.2 ECG Sensors .......................................................................................................6-2

6.2.3 Airflow Sensors ...................................................................................................6-2

6.2.4 Snore, Actimeter, and Body Position Sensors .....................................................6-2

6.2.5 Effort Belts ..........................................................................................................6-2

Chapter 7: Troubleshooting ........................................................................................................7-1

Chapter 8: Specifications ............................................................................................................8-1

ment so you can successfully run your sleep studies. It provides detailed information on:

•Alice 5 equipment setup

•Alice Sleepware software installation

•Alice 5 equipment user instructions

Refer to the following Alice manuals for additional information:

software and describes the reporting features within Sleepware.

The Alice 5 system contains the following hardware components, shown in Figure 1–1:

general list of accessories available. For a complete list, contact Respironics Customer Service or

your Respironics representative.

• Computer workstations • Computer monitors

• Laptop computers • Ethernet cards

• Computer speakers • Network switches

•Effort sensors • Oximeter sensors

• Oximeter probes • Cannula

• Additional User Guides

tested by Respironics. For recommended computer specifications, see the Alice

approved.

may differ from the ones shown in illustrations in this manual.

Caution: US federal law restricts this device to sale by or on the order of a licensed

healthcare practitioner. This product should be used only under the supervision of

a physician.

The following warnings indicate the possibility of injury to the patient or the operator.

signals are required for the Alice 5 to function. Even though the system contains methods

and techniques that can provide protection from external sources of interference, you

should operate the system as follows:

defibrillation. Remove all patient leads (applied parts) before performing cardiac defibril-

Connections should not be made to these connectors unless ESD precautionary proce-

On the back of the base station, there are two LEDs located on the ethernet connection ( ):

Network Present and Network Traffic. These LEDs function for both wired and wireless net-

•Flashing Green – Indicates that there is traffic on the network.

•Flashing Yellow – Indicates that the only connection is to a wireless network.

•Green – Indicates that the network is a wired network.

specific to auxiliary inputs 1 and 2, but you can use the same information for the remaining

back of the base station. The following table contains the proper pin-out information for the serial

connection port.

The Alice 5 headbox combines the neurological inputs and cardio-respiratory inputs into a single

device. These signals are then sent to the Alice 5 base station. You can place the headbox in

several different locations:

•Attached to a carrying strap that the patient can wear around the neck. This option is

Figure 1–5 illustrates the options for headbox placement.

Figure 1–6 shows the Alice 5 headbox and defines the connections.

side of the device. Connect the right reference electrode to the A2 input jack on the

right side of the device.

See Chapter 4 for more information on connecting sensors to the headbox.

The following symbols appear on the Alice 5 base station and headbox.

CPAP Continuous Positive Airway Pressure

Configuration The set of channels used to acquire polysomnographic data.

used to score wake and sleep and to identify sleep stages. The EEG

wake and sleep and to identify sleep stages.

EOG Electrooculogram – A recording of voltage changes resulting from

shifts in position of the eye. Along with the EEG and EMG, the

EOG is one of the three basic variables used to score wake and

sleep and to identify sleep stages.

EPAP Expiratory Positive Airway Pressure

presentation (display). Generic channels usually have as their

source an auxiliary device connected to an auxiliary input on the

Alice headbox. Generic channels may be displayed as numbers or

Graphic Display Type One of three display types for generic channels. A graphic display

type is assigned when a channel’s data is most useful to the

clinician when displayed as a graph (waveform) rather than a

number, and the data points of the curve are not clinically useful.

In other words, the curve, not its data points, are important.

Grapho-Numeric Display Type

One of three display types for generic channels. A grapho-numeric

Headbox A bedside remote amplifier that is part of the Alice system and is

Infrastructure Network An integrated wireless and wired LAN is called an infrastructure

IPAP Inspiratory Positive Airway Pressure

the device packaging.

Montage A montage (as distinguished from an acquisition configuration) is a

reference. The montage tool recombines EEG/EOG data in order to

display the difference in potential between any two electrodes.

Numeric Display Type One of the three display types for generic channels. A numeric

pH A measure of the acidity or alkalinity of a fluid. In sleep, this

generally refers to a measure of the acidity of fluid in the esopha-

gus, detected by an esophageal pH probe.

PLM Periodic limb movement, indicated by the change in leg muscle

tone as detected by the difference in electrical potential of two leg

Polysomnography Recording of multiple channels of physiologic data during sleep.

PSG Polysomnography

REM Rapid Eye Movement – The stage of sleep with the highest brain

activity, characterized by enhanced brain metabolism and vivid

Any devices tested and approved as “Wi-Fi Certified” by the Wi-Fi

Alliance are certified as interoperable with each other.

6443 (US or Canada only) and 1-724-387-4000.

Additionally, you may contact Respironics Customer Service at the following email address:

addresses for each piece of equipment.

If you plan to have several patient rooms and several Alice 5 systems or computers, you may

want to set your equipment up using a wired network setup. Figure 2–7 provides an example.

Note:Refer to IEC 60601-1-1 for definition of the patient environment.

Bedroom 3

If you plan to have multiple patient rooms with several Alice 5 systems and computers and you

want to connect a portion or all of your network wirelessly, you can use an Access Point Infra-

structure network. Figures 2–8 and 2–9 show examples of possible setups.

Figure 2–8 shows a network in which multiple computers are connected to multiple Alice 5

Once you have determined which type of setup you will be using (point-to-point, ad-hoc, wired

network, or access point infrastructure network), you can connect your Alice 5 equipment.

Figure 2–10 provides a detailed illustration of how different devices and cables are connected to

the back panel of the base station. The steps that follow refer to many of the connectors shown in

Figure 2–10.

Complete the following steps to set up your Alice 5 hardware. Refer to Figure 2–12 for a detailed

example of how the final room setup might look.

tions supplied with it.

2. Unpack your Alice 5 system and make sure that all of the components are included.

pillow, or on a nearby hook using the carrying strap supplied with your system. Or, use the

Note: The ends of the Patient Cable are interchangeable. It does not matter which end you

plug into the base station and which end you plug into the headbox.

you can enable the audio feature by right-clicking on the Room button located on the

2.4, Adding Accessories, for instructions on setting the audio and video settings.

12. If you are using speakers with your system, connect the green, male end of the Speaker cable

volume control on the speakers or you can use the volume control setting on your computer.

13. To connect a Respironics therapy device (CPAP, Bi-Level, etc.) to the Alice 5 system, connect

the serial connector end of the therapy device’s Communications Cable into the Com 1 Serial

Connection port ( ) on the back of the base station. Connect the remaining end of the

Communications Cable to the port on the back of the therapy device or to the Sleeplink card,

if applicable. This allows you to control the therapy device directly through the Alice 5

system. Refer to the therapy device’s manual for connection information.

14. If desired, you can connect additional external medical devices, produced by other manufac-

turers, using the Auxiliary Input connectors on the back of the base station. Refer to these

Figures 2–12 and 2–13 provide a more detailed example of how a network setup may look.

BEDROOM 1

BEDROOM 2

2. If one or more restricted users will be running Alice Sleepware, the permissions on the

installation directory must be opened so that everyone has both read and write access to

all applicable files.

choice between applying changes to “this folder only” or to “this folder, subfolders,

and files.” Choose the second option to apply changes to all of the folders/files.

3. If acquisition data will be shared by multiple restricted users, or if the user recording the

data and the user scoring the data are two different restricted users, then the permissions

on all data locations must be opened so everyone has read and write access.

After installation is complete, if multiple restricted users will be using the software, you will also

computer if necessary.

Complete the following steps to install the Alice Sleepware software.

Note: It is recommended that you close all other software programs before installing the

1. Insert the Sleepware CD into your computer’s CD drive.

2. In the first screen, shown in Figure 3–1, select Install Software.

Note: The version numbers shown on the screens in this manual are for example only. Your

software version may differ from the one shown here.

3. In the next screen, select one or both of the following items if they apply to you, as shown in

cally launch upon logging in. If you do not check this box, you will have to manually

5. Specify the directory where you want the software program to be installed (or use the default

directory shown), and click Install, as shown in Figure 3–3.

After the installation is complete, the following software shortcut icons are automatically

placed on your desktop for easy access to the software:

Through the Alice Sleepware software, you can add Alice 3, 4, or 5 devices. This section de-

3. A list of Alice 5 devices that are configured to communicate with your computer appears. If

there are no Alice devices currently configured, the list will be empty, as shown in

4. The Alice 5 Configuration Wizard appears as shown in Figure 3–10. Click Next.

the IP address of that same device, you must return to the Add/Modify screens and

reconfigure the device using its new IP address; otherwise, the device will no longer be

found on the network.

If you want to update your settings, click the Edit buttons to the right of the fields and do the

need to go to Start>Settings>Control Panel in the above step.

8. If your device appeared in the list of devices on the screen shown in Figure 3–15, after you

highlight the device you want to add and click Next, the screen shown in Figure 3–18

appears. This screen will be different depending on whether you specified that you have a

wired or wireless network on the screen shown in Figure 3–14. If you specified that the Alice

5 is connected through a wired interface, the screen shown in Figure 3–18 appears. If you

specified that the Alice 5 is connected through a wireless interface, the screen shown in Figure

•In the Alice 5 Network Settings fields, type in the TCP/IP address, subnet mask, and

gateway information for the Alice 5 device so your computer will be able to fully

communicate with the device on the network.

a. In the TCP/IP Address field, type in the unique TCP/IP address for your Alice 5

device’s IP address will not be necessary if you use this type of configuration.

b. Type in the correct Subnet Mask for your Alice 5 device. A subnet mask is like a

c. If your Alice 5 device is not on the same subnet as your computer, you need to

•In the first field, type in a customized name for your Alice 5 device so you and your

colleagues can easily identify the device on your network in the future.

a. In the TCP/IP Address field, type in the unique TCP/IP address for your Alice 5

device’s IP address to a unique address. Each Alice 5 device has its own unique wired

and wireless IP address based on the serial number on the device, so changing the

device’s IP address will not be necessary if you use this type of configuration.

Note:If you do not know the TCP/IP address for your Alice 5 device, contact your network

administrator.

b. Type in the correct Subnet Mask for your Alice 5 device. A subnet mask is like a

c. If your Alice 5 device is not on the same subnet as your computer, you need to

b. If you selected Ad-Hoc for the wireless network mode, you will need to select

Note: If you select Infrastructure for the wireless network mode, you will not need to select

a channel. The Channel field will be grayed out.

Note: All points in your wireless network must use the same key to utilize encryption.

The Acquisition Data Recipient screen appears, as shown in Figure 3–20.

stored on the base station, unless you run this wizard again on a different computer and

designate that computer as the data recipient.

this Wizard on another computer in the network and choose Option 1 for that com-

puter.

10. If the wireless interface is disabled (because you did not check the Enable Wireless Interface

box in Figure 3–19), the Wireless Interface Disabled screen appears, as shown in Figure 3–21.

This screen indicates that the wireless interface on the Alice 5 device is currently disabled. To

enable the wireless interface, you will need to edit the device properties by clicking on the

Additionally, once the device is successfully added, a Room button appears in your Alice

Sleepware starter bar, indicating the device’s status, as shown in Figure 3–23.

device properties through the Add/Modify Device screens. For more information, refer

This chapter describes how to set up the patient so the data you need will be properly recorded,

and instructs you on how to start and stop an acquisition. See Chapter 5 for information on the

providing tracking of patient recording history. Multiple acquisitions performed on one patient

may be easily located within the database.

detailed view of the recording can be seen by scrolling through the data. You may select the

channels displayed on the screen and the color of the raw data, and print any raw data screen or

groups of screens. Global patterns or trends for the recording may be viewed via the use of

1-hour or 10-hour summary screens. You can view video of the patient while they sleep, and you

can save streaming video or snapshots along with the sleep data.

Alice Sleepware automatically detects physiologic events such as apnea, hypopnea, snoring,

periodic limb movements, heart rate, arrhythmia, pH, and arousal. Events may also be distin-

Complete the following steps to attach the chest and abdomen sensors to the patient:

example, an apnea monitor), follow the manufacturer’s guidelines for attaching the

should hang straight in front of the patient.

2. Plug the lead into the Alice 5 headbox.

Also, check the tension of the effort belts before and after feedings. As the infant

eats, his or her belly may expand and the belts may become uncomfortably tight.

Complete the following steps to attach the airflow sensor to the patient:

1. Make sure you have the proper size sensor for your patient; both adult and infant sizes are

cannula protruding slightly into the nostrils. Trim if necessary per the manufacturer’s guide-

thermistor sensor is readable to the technician if the sensor is applied properly.

oximeters, apnea monitors, etc. These can be connected to the auxiliary input ports on

the back of the Alice 5 base station. See Chapter 1 for more information about the

auxiliary input ports. Follow the manufacturer’s instructions for attaching these

sensors to the patient.

Refer to Figure 1–6 and Section 4.2, Patient Setup, for more information.

Figures 2–10 and 2–11.

2. Check the auxiliary device connections (if applicable).

specified during the channel setup. See Chapter 5, Understanding Channels, for more

3. Check the base station connections.

If you are using a wired network connection, make sure the ethernet cable is inserted into the

Check impedance and calibration by completing the following procedures.

ing the physiological data that is being recorded. You won’t lose any physiological signals when

viewing impedance. To check impedance, complete the following steps:

1. Set up the appropriate sensors.

Note: The impedance feature works for the EEG, EOG, ECG, and EMG channels.

3. Start an acquisition as described in Section 4.3.3.

The Alice equipment begins capturing data from the sensors.

4. Click on the Imped. button while viewing the acquisition through Sleepware.

The Sleepware software continuously displays the impedance value for each channel. The

channel tabs to the left of each channel displayed indicate the impedance value by color:

•A red tab indicates a high impedance value (a poor connection).

•A dark green tab indicates a moderate impedance value (a fair connection).

you press Imped.

Note: The threshold values for impedance are user-configurable.

5. Use the information in Table 4–3 to determine whether further action is needed.

1. Set up the sensors as described in Section 4.2.

2. Connect all of the required cables and check the connections as described in Section 4.3.1.

3. Start an acquisition as described in Section 4.3.3.

1. Set up the sensors as described in Section 4.2.

3. Start an acquisition, as described in Section 4.3.3.

1. Configure the Communication Settings for connection to the Alice 5 device you are using (see

the Alice Sleepware User’s Guide for instructions on configuration).

The name of your device appears in the Starter bar at the top of the computer screen, along

3. Click on the name of the device.

The Acquisition Launch screen appears as shown in Figure 4–7.

4. Click on Start to begin the acquisition.

The On-Line View screen appears, displaying all of the acquisition data. Green on the Alice

Starter bar and the On-Line View screen indicates that the connection is successful and the

Note: It is recommended that you start an acquisition through the Sleepware software.

However, if this is not available, you can press the Record Start/Stop button on the

base station. The Record LED is green while the base station records data.

Channels refer to the different types of data collected by the auxiliary devices and sensors

connected to the patient. The set of channels used in any particular sleep study is referred to as a

study. Once you set up the patient and have the data coming in from the channels you configured,

you can use the Alice Sleepware to filter channels, create a montage, etc. Refer to the Alice

Sleepware User’s Guide for information on how to build configurations and create montages.

The EOG channel type is used to display data from an electrooculogram channel. You can

select customized parameters for this channel. After customizing your configuration, you

can use the Label function to enter a text description for your configuration of up to eight

The snore input is not calibrated.

The pleth channel type is used to display (as a waveform) changes in arterial blood flow

detected by the Masimo sensor.

The pulse rate channel type is used to display numerical data from the Masimo pulse

oximeter. To use the pulse rate channel type, connect a finger probe through a patient

interface cable to the oximeter connection on the headbox.

detailed description of pulse rate channel features. After customizing your configuration,

you can use the Label function to enter a text description for your configuration of up to

tion, you can use the Label function to enter a text description for your configuration of

up to eight characters.

correctly in the Alice Sleepware. See the Alice Sleepware User’s Guide for more informa-

There are eight auxiliary input ports on the base station. You can use these ports to connect third-

party therapy or monitoring devices to the Alice 5. Depending on the auxiliary devices you use,

there are many possible auxiliary input channels available. Some of the key channels that you can

Each auxiliary channel display property is described in greater detail below.

The graphic display type allows you to display any signal as a waveform. Examples of such

signals are airflow, effort, plethysmograph, etc. Generally, the graphic display type is designed to

produce a waveform for signals whose sample values are not given in meaningful units.

Because the graphic display type is multi-purpose, the Alice Sleepware cannot analyze the data

recorded on a channel using this display type. This differentiates the graphic display type from

standard channel types, such as the airflow channel. Both provide waveforms, but Alice can only

scan the standard channel type, not the channel using the graphic display.

defined voltage range.

the data recorded on a channel using this display type. This differentiates the grapho-numeric

display type from standard channel types, such as the airflow channel. Both provide waveforms,

display.

The numeric display type allows you to display a signal from an auxiliary device as a series of

numerical values. Examples of such devices are oximeters, EtCO2 monitors, pH units, CPAP or

bi-level devices, etc. Any device that has an analog output can be viewed using the numeric

display type, though some signals are better viewed as graphs.

when viewing auxiliary channel data.

Note: The default frequency for numerical data is 1 Hz, as this is the maximum frequency at

base station:

headbox for each channel.

• The Recorded Frequency (in Hertz) column tells you how often the data is recorded per

second. Many channels have several frequency rates available. You can choose how often

you want these channels to record through the Alice Sleepware.

including SpO2, CPAP, EPAP, IPAP, EtCO2, and pH. For information about the SpO2 channel, see

Section 5.1. For information about the CPAP, EPAP, and IPAP channels, see Section 5.3.

The EtCO2 channel is used to display an end tidal carbon dioxide signal from an EtCO2

tion, you can use the Label function to enter a text description for your configuration of

Connect the pH channel signal to an auxiliary input on the back of the base station (see

Figure 1–4).

correctly in the Alice Sleepware. See the Alice Sleepware User’s Guide for more informa-

If you are connecting a Respironics therapy device to the COM 1 serial port on the back of the

base station or a third-party therapy device to one of the auxiliary input ports on the base station,

several therapy device channels are available. This section describes the therapy device channels

•Aria LX

•BiPAP Pro

•Virtuoso LX

The therapy device channels that are available for reporting are described below.

pressure devices in CPAP mode. You can customize the CPAP channel type to accommodate

station (see Figure 1–4 for auxiliary port location).

The high pressure is called Inspiratory Positive Airway Pressure (IPAP).

station (see Figure 1–4).

of the base station (see Figure 1–4).

you can use the Label function to enter a text description for your configuration of up to eight

When the base station receives this channel type through an auxiliary input, you can configure

parameters for the channel so that the input signal is displayed correctly in the Alice Sleep-

The IPAP channel type is used to display bi-level positive airway pressure signals from bi-

level pressure devices. These devices sense, through the use of an integral transducer, if the

patient is either inhaling or exhaling. If the patient is exhaling, the bi-level pressure device

supplies less airway pressure. The low pressure is called Expiratory Positive Airway Pressure

(EPAP). If the patient is inhaling, the bi-level pressure device supplies more airway pressure.

Figure 1–4).

base station (see Figure 1–4).

When the base station receives the IPAP channel type through an auxiliary input, you can

configure parameters for the channel so that the input signal is displayed correctly in the Alice

Sleepware. See the Alice Sleepware User’s Guide for more information.

There are a few channels that can also be derived from the physical inputs and the auxiliary

inputs on the headbox and base station. These derived channels are described below.

between the R pulse on your ECG signal and the actual peak of the flow in your Pleth

waveform. It determines the time it takes between the heartbeat and the flow of blood at the

finger, as determined by the pulse oximeter.

Note: Auxiliary channels do not provide isolated inputs. Medical devices which are con-

nected to the auxiliary inputs on the base station must be Type BF applied parts and

must provide any necessary additional isolation from the base station.

The Alice 5 system is designed to conform to the following standards: IEC 60601-1, EN 60601-1,

The Alice 5 hardware is classified as follows:

•Type of Protection Against Electric Shock: Class I Equipment

or nitrous oxide

Do not connect any devices to the base station auxiliary inputs that have signal voltages greater

leakage current requirements.

Humidity:15% to 95% RH non-condensing 15% to 95% RH non-condensing

Display: 1-100% (SpO2 display is functional saturation.)

0 - 69% unspecified

specifications, refer to the Masimo packaging and documentation supplied with the

probe.

This device is intended for use in the electromagnetic environment specified below. The user

of this device should make sure it is used in such an environment.

This device is intended for use in an electromagnetic environment in which radiated RF

communications equipment (transmitters) and this device as recommended below, according