Resmed Sleep Screening Tool Apnealink Users Manual 1011262 1 Broch
ApneaLink to the manual cef51901-e13c-4986-94b7-c432afc4cf90
2015-02-06
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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). 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, providing 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 sleepscreening 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 Why use ApneaLink? ApneaLink without oximetry 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 dramatically increasing the number of identified SDB patients through primary care and specialty referral sources, thereby routing more patients for diagnosis to a sleep center. 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: How does ApneaLink work? • Uses one software set for both ApneaLinks (with and without oximetry) 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-tointerpret 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. • Add oximetry at any time, no software changes required—simply “plug & play” • Automatically analyzes and derives AHI, AI and HI, flow limitation and snoring • 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 10 2 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 singleuse patient sensors. The original ApneaLink software has been enhanced to show a two-page patient report with pulse and oximetry signals, detailed SpO2 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. Electromagnetic Compatibility TECHNICAL SPECIFICATIONS APNEALINK AND PULSE OXIMETER Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC606011-2, for residential, commercial and light industry environments. For further details, see “Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity” as follows. Signal Recording Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity Breathing sounds Respiratory flow Blood oxygen saturation Pulse Battery voltage 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 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 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 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. Harmonic Emissions IEC 61000-3-2 — Voltage fluctuations/ flicker emissions IEC 61000-3-3 — 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. 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 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. 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 ORDERING INFORMATION & PRODUCT CODES ApneaLink Operating/Storage Air Pressure 800 hPa to 1060 hPa 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 Nasal Cannulas (25/pk) ApneaLink Oximetry Accessories Kit Tape, Sensor (for Flex Wrap Sensor), (25/pk) 70276 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") 22302 Optional Accessories and Disposables (US, Latin America and Canada) US and Latin America US and Latin America 22304 Canada 1 Nonin XPOD oximeter 1 Sensor clip 3 Disposable Sensors 22308 Nasal/Oxygen Cannula (25/pk) Belt, reusable 70388 70319 629052 Belt, Single Use (24/pk) 70406 Sensor, Oximeter-Single Use 70412 Sensor, Oximeter (Flex Wrap)-Reusable 1431002 Sensor, Oximeter (Soft Sensor)-Reusable 70413 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
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