Watermark Medical ARES 610 Product Manual
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Watermark Medical ARES 610 Product Manual

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ARES 610 PRODUCT GUIDE
www.watermarkmedical.com

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Summary of Contents for Watermark Medical ARES 610

  • Page 1 ARES 610 PRODUCT GUIDE www.watermarkmedical.com...
  • Page 2 If you have any questions regarding this product, please first refer to this guide. To obtain warranty service, you must call Watermark Medical and speak with a Customer Service Representative. Be prepared to provide: 1) your name, address and telephone number, 2) the ARES model and serial numbers, and 3) an explanation of the problem.

  • Page 3: Table Of Contents

    PREPARING THE ARES 610 FOR USE ........

  • Page 4: Safety Information And Introduction

    SafETY InfORMaTIOn and InTROdUCTIOn A. About the Apnea Risk Evaluation System (ARES) The Apnea Risk Evaluation System (ARES ) provides an integrated approach to assist in the diagnosis of obstructive sleep apnea (OSA). The ARES design combines existing knowledge on sleep-disordered breathing with an easy-to-apply data acquisition system.

  • Page 5: Safety

    In the interest of continued product development, Watermark Medical reserves the right to make changes and improvements to this guide and the products it describes, at any time, without notice or obligation.
  • Page 6 7. Do not expose the device to patients with active infectious disease where the use of barrier precautions is advised. The device cannot be used with any other patient and must be returned to Watermark Medical for destruction. Replacement charges are the responsibility of the customer.
  • Page 7 NOTE: If a device is used with a person with active, infectious disease the customer must alert Watermark Medical and arrange for the return of the device through Customer Support. The device cannot be used on any other patient and must be returned for destruction.
  • Page 8 7. In less than 0.1% of cases, patients may experience a red mark appearing on the forehead after the study. The mark is similar to a sore that sometimes occurs when a patient wears a CPAP mask. This mark is normal and usually disappears in a few hours.

  • Page 9: Preparing The Ares 610 For Use

    PREPaRInG THE aRES 610 fOR USE A. About Cleaning and Replacing Disposables The forehead sensor, enclosure pad, and ARES enclosure must be cleaned and the enclosure strap, nasal cannula and EEG disposables must be replaced after each patient use. After the disposables have been replaced the ARES must be placed in a clean resealing bag.

  • Page 10: Removing The Disposable Components With Eeg

    B. Removing the Disposable Components with EEG Remove the EEG sensors by grasping the Enclosure strap and the EEG flex cable with one hand and pulling on the EEG sensor with the other. 1. Unsnap the Enclosure strap from the Stabilizing Straps. 2.
  • Page 11 Procedure: 1. Remove the clear plastic sheet covering the forehead sensor. 2. Apply a small amount of alcohol-based hand sanitizer meeting CDC hand hygiene guidelines to your index finger. 3. Push down the long edge of the forehead sensor closest to the plastic Luer lock and gently lift up the other long side of the forehead sensor.
  • Page 12 6. Perform Steps 1—5 again using a 70% alcohol pad instead of hand sanitizer. (See photos below. 7. Let the unit air-dry; the alcohol drops will dry in approximately 30-60 seconds. 8. Look underneath the forehead sensor and ensure the cable is feeding directly though the hole in the sensor enclosure pad.

  • Page 13: Replacing The Nasal Cannula

    • The forehead sensor is recommended to be replaced after approximately 60 nights of use or when the sensor surface becomes pitted or cracked. The forehead sensor is not covered by the warranty. Use care when cleaning to maximize life of this sensor. D.

  • Page 14: Recharging The Ares Battery

    E. Recharging the ARES Battery CAUTION: The ARES should only be recharged by trained staff. CAUTION: The ARES should only be recharged by trained staff. CAUTION: Do Not Touch the metal snaps on the flex circuit during charging. CAUTION: Do Not Touch the metal snaps on the flex circuit during charging. 1.

  • Page 15: Replacing The Enclosure Strap And Eeg Sensors

    F. Replacing the Enclosure Strap and EEG Sensors CAUTION: If the Stabilizing Straps become damaged the result can be poor CAUTION: If the Stabilizing Straps become damaged the result can be poor signal quality with compromised test. Number Description of Component Number Description of Component EEG Sensor Snap EEG Flex Circuit EEG Sensor...

  • Page 16: Acquiring And Processing A Sleep Study

    PROCESSInG a SLEEP STUdY The ARES device is operated through the Watermark Medical Website. The ARES Portal is used to perform basic operations for completing a home sleep test, including initializing the device for user, downloading and processing the study, and retrieving study results.

  • Page 17: Dispensing The Ares To The Patient

    D. Dispensing the ARES to the Patient 1. Review the ARES Dispensing instructions with the patient. 2. Measure the head circumference of the patient and adjust the strap according to the table. (See the ARES Dispensing Instructions document for measurement instructions.) 3.

  • Page 18: Ares 610 Specifications

    610 SPECIfICaTIOnS Environmental Operation Transportation Storage Conditions 5°C to 40°C -20°C to 70°C -20°C to 70°C Temperature 41°F to 104°F -4°F to 140°F -4°F to 140°F -390m to 3,012m -390m to 3,012m -390m to 3,012m Altitude -254 ft. to 9.882 ft.

  • Page 19: Audio Signals And Interpretation

    Audio Signals and Interpretation Event Sound When audio...

  • Page 20: Table 204

    Table 204 Guidance and Manufacturer’s declaration — Electromagnetic Immunity • Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

  • Page 21: Patent And Trademark Acknowledgements

    • The ARES is patented in the United States (P/N 6,811,538), Australia, and other patents pending. • ARES, ARES Manager and ARES Insight are trademarks of Watermark Medical Inc., Atlanta, GA. • Windows is a trademark of Microsoft Corporation. •...
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  • Page 24 ARES 610 PRODUCT GUIDE SM-0003 REV.07...

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