Resmed Sleep Screening Tool Apnealink Users Manual 1011262 1 Broch

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ApneaLink™

Your link to better sleep health

ApneaLink is a simple, cost-effective

sleep-screening tool that objectively

identifies patients at risk for obstructive

sleep apnea (OSA).

Why use ApneaLink?

Sleep-disordered breathing (SDB) is recognized as a serious

health problem that impacts about 43 million US adults;

however, more than 80% remain undiagnosed and untreated.

1

The ApneaLink connects clinicians to their patients by dramati-

cally increasing the number of identified SDB patients through

primary care and specialty referral sources, thereby routing

more patients for diagnosis to a sleep center.

How does ApneaLink work?

The basic ApneaLink is a single-channel screening device

that uses a simple nasal cannula to record patient breathing.

It automatically analyzes and derives AHI, flow limitation and

snoring and later automatically generates a simple, easy-to-

interpret report with a color-keyed Risk Indicator for the

clinician to review.

With oximetry, the ApneaLink records three channels of

information: respiration, oximetry and pulse.

Simplicity, cost-effectiveness and state-of-the-art technology combine in the ApneaLink,

the ultimate choice for homecare providers, sleep labs and clinicians. The ApneaLink is one of

the few true sleep-screening devices available for obstructive sleep apnea (OSA) patients, pro-

viding the link to an improved quality of life by cost-effectively testing chronic disease patients,

intra-hospital pre-op surgical patients, occupational health patients and other high-risk patients.

The ApneaLink readily transitions patients from referring physicians to sleep centers.

ApneaLink is portable, battery-powered and user-friendly and will streamline any user’s sleep-

screening process. A versatile tool, ApneaLink can be used in the patient’s home in remote

locations (or any location where patients are sleeping).

Three easy steps can link you to more OSA patients and, most importantly, provide them

a better quality of life:

1 Screening – ApneaLink

2 Diagnosis – Polysomnography

3 Treatment – ResMed PAP therapy

ApneaLink without oximetry

The basic ApneaLink is the perfect choice for

those who need a cost-effective, accurate

screening tool. Reliable and simple to use, the basic

ApneaLink offers the following features and benefits:

• Add oximetry at any time, no software changes

required—simply “plug & play”

• Automatically analyzes and derives AHI, AI and HI, flow

limitation and snoring

• Uses one software set for both ApneaLinks (with and

without oximetry)

• Auto-generates a simple, easy-to-interpret one-page report

with a color-keyed Risk Indicator

• Can be used to identify intra-hospital preoperative patients

at risk for SDB, thereby improving overall quality of care

• Enables referral sources to easily and objectively determine

whether to refer a patient for further evaluation

• Cost-effectively screens chronic disease patients, drowsy

drivers and other high-risk individuals

• Improves patient care by providing quicker access to the

treatment care path

• Sensitivity 100%, specificity 87.5% at AHI of 102

1 Young et al. State of the Art, AJRCCM 2002

2 Wang Y et al. Pneumologie 2003

ApneaLink with oximetry

ResMed’s ApneaLink with oximetry is the premium choice in

screening for OSA. In addition to the features and benefits of

the basic ApneaLink device, the pulse oximeter provides two

additional channels of information—pulse and pulse oximetry,

all three channels in a simple “little blue box.” A simple nasal

cannula is used for sensing patient breathing. Oximetry and

pulse are detected using a choice of either reusable or single-

use patient sensors. The original ApneaLink software has been

enhanced to show a two-page patient report with pulse and

oximetry signals, detailed SpO

2

information and waveform data.

The ApneaLink with oximetry is perfect for those who want

more information and are expanding their screening capabilities

to other non-traditional patient areas, such as home oxygen

patients.

ResMed Corp Poway, CA, USA +1 858 746 2400 or 1 800 424 0737 (toll free), ResMed Ltd Bella Vista, NSW, Australia +61 (2) 8884 1000 or 1 800 658 189 (toll free). Offices in Austria, Brazil, Finland, France, Germany, Hong Kong, Japan,

Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, United Kingdom (see website for details).

ApneaLink is a trademark of ResMed Ltd. and is registered in U.S. Patent and Trademark Office. ©2006 ResMed. 1011262/1 06 10

Global leaders in sleep and respiratory medicine www.resmed.com

ApneaLink

US and Latin America 22302

Canada 22303

1 Apnealink device 1 Program CD

3 Nasal Cannulas 2 AA Batteries

1 Reusable Belt 1 Carrying Case

1 Quick Software Setup Guide

1 USB download cable

ApneaLink Oximetry Accessories Kit

US and Latin America 22304

Canada 22308

1 Nonin XPOD oximeter

1 Sensor clip

3 Disposable Sensors

TECHNICAL SPECIFICATIONS

APNEALINK AND PULSE OXIMETER

Signal Recording

Breathing sounds

Respiratory flow

Blood oxygen saturation

Pulse

Battery voltage

Sampling Rates for the Channels

Respiratory flow/breathing sounds: 100 Hz

Saturation: 1 Hz

Pulse: 1 Hz

Battery: 1 Hz

Signal Processing

Signal recording: 20 Bit

Signal storage: 16 Bit

Internal Memory

Storage capacity: 15 MB

Recording period: 8 hours minimum

Power Supply to Recorder

2 NiMH rechargeable batteries: Mignon/AA/1.2V/

at least 2.1 Ah or

2 batteries: LR 6/Mignon/AA/1.5V/at least 2.1 Ah

Weight

Recorder (without rechargeable batteries or batteries):

Approximately 50 g (1.8 oz)

Pulse Oximeter: Approximately 30 g (1.1 oz)

Operating Conditions

Temperature: 20°C to 40°C (68°F to 104°F)

Humidity: 10% to 90% RH (non condensing)

Shipment/Storage Conditions*

Temperature: -20°C to +50°C (-4°F to +122°F)

Humidity: 10% to 90% RH

*Recorder without rechargeable batteries or batteries

Operating/Storage Air Pressure

800 hPa to 1060 hPa

Effective Range

Flow sensor: -10 hPa to +10 hPa

SpO2: +/- 2 digits

Pulse: +/- 3 digits

Interfaces

Nasal pressure cannula: Luer connection

Pulse oximeter: 3-pin Binder plug

Computer: Fullspeed USB 1.1

Dimensions

Recorder (length x width x height): 125 x 60 x 30 mm

(4.9" x 2.4" x 1.2")

Pulse oximeter: (length x width x height): 53 x 20 x 15 mm

(2.1" x 0.8" x 0.6")

Electromagnetic Compatibility

Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-

1-2, for residential, commercial and light industry environments. For further details, see “Guidance and

Manufacturer’s Declaration – Electromagnetic Emissions and Immunity” as follows.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity

The ApneaLink is intended for use in the electromagnetic environment specified below. The customer or user

of the ApneaLink should ensure that the system is used only in such an environment.

Emissions test Compliance Electromagnetic environment—guidance

RF emissions CISPR11 Group 1 The ApneaLink uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are unlikely to cause

any interference in nearby electronic equipment

RF emissions CISPR11

Harmonic Emissions

IEC 61000-3-2

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Class B

—

—

The ApneaLink is suitable for use in all establishments, including

domestic establishments and those directly connected to the

public low-voltage network that supplies buildings used for

domestic purposes.

Optional Accessories and Disposables

(US, Latin America and Canada)

Nasal Cannulas (25/pk) 70388

Nasal/Oxygen Cannula (25/pk) 70319

Belt, reusable 629052

Belt, Single Use (24/pk) 70406

Sensor, Oximeter-Single Use 70412

Sensor, Oximeter (Flex Wrap)-Reusable 1431002

Tape, Sensor (for Flex Wrap Sensor), (25/pk) 70276

Sensor, Oximeter (Soft Sensor)-Reusable 70413

ORDERING INFORMATION & PRODUCT CODES

Medical Electrical Equipment needs special precautions with respect to EMC and needs to be installed and

put into service according to EMC information provided in this document.

Warnings: The ApneaLink should not be used adjacent to or stacked with other equipment. If adjacent or

stacked use is necessary, the ApneaLink should be observed to verify normal, operation in the configuration

in which it will be used. The use of accessories other than those specified in this manual is not

recommended. They may result in increased emissions or decreased immunity of the ApneaLink.