www.watermarkmedical.com
ARES 610 PRODUCT GUIDE
Page 1: ...www watermarkmedical com ARES 610 PRODUCT GUIDE ...
Page 2: ...presentative 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 Telephone 877 710 6999 Monday Friday 8 00 AM to 5 00 PM Eastern Standard Time Fax 561 208 6237 Web www watermarkmedical com Mailing 1117 Perimeter Center West Suite W514 Atlanta GA 30338 Watermark Medical Inc 1117 Perimeter Center West Suite W514 Atla...
Page 3: ...acing the Nasal Cannula 10 E Recharging the ARES Battery 11 F Replacing the Enclosure Strap and EEG Sensors 12 G Placing the ARES in a Clean Resealing Bag 12 ACQUIRING AND PROCESSING A SLEEP STUDY 13 A Initiating a Study 13 B Downloading Patient Data 13 C Reviewing Sleep Study Reports 13 D Dispensing the ARES to the Patient 14 ARES 610 SPECIFICATIONS 15 General Compliance 15 Audio Signals and Inte...
Page 4: ...r capable of recording oxygen saturation pulse rate snoring level head position movement and nasal pressure The ARES is easily placed on the forehead by the user and comfortably worn for 8 10 hours The ARES provides sufficient battery capacity for two nights of recordings after seven continuous hours of recording the ARES conserves power by automatically going into sleep mode The battery must be r...
Page 5: ...titute for clinical pulse oximetry The ARES is a recording device not a monitoring device Warnings 1 Explosion Hazard Do not use the ARES in the presence of or store near Flammable anesthetics or gases High temperatures such as fire Enclosed areas in direct sunlight 2 Warranty void if repairs disassembly are performed by non approved personnel Cautions General 1 The ARES should be prepared for use...
Page 6: ...f any indicator is not lit do not use the ARES Contact Customer Support for repair or replacement 877 710 6999 10 For hygienic purposes replace all disposable components i e the enclosure strap and nasal cannula etc after each patient use 11 Always inspect and then disinfect the forehead sensor according to the recom mended guidelines The forehead sensor is recommended for replacement after approx...
Page 7: ... charges e Inability to sleep at least 5 hours per night or a total of 8 hours over two nights f Inability to sleep with head reclined less than 60 degree angle g Head circumference less than 20 inches or greater than 25 inches Use of the ARES by patients with any of these conditions may result in poor signal quality that could lead to a misdiagnosis by the physician 4 The proper use of the ARES r...
Page 8: ...ge the ARES batteries only using the wall charger provided 3 Do not attempt to charge the ARES with a charger from another product 4 Do not rely on the USB port on a computer for proper charging 5 For optimal performance use fully recharged batteries 6 The wall charger should not be sent home with the patient 7 Follow local ordinances and recycling instructions regarding disposal or recycling of t...
Page 9: ...ew the Nasal Cannula luer lock from the Enclosure luer lock 2 Remove the EEG sensors enclosure strap and nasal cannula 3 Initialize the ARES 4 Recharge the batteries 5 Apply non latex gloves and clean the sensor 6 Clean the enclosure 7 Replace the strap 8 Apply new EEG sensors 9 Apply new nasal cannula 10 Place the ARES in customized packaging 11 Upload patient information COMPONENT DESCRIPTION 1 ...
Page 10: ...Straps 2 Unscrew the Nasal Cannula from the Cannula Luer Lock on the Enclosure 3 The disposable components are single use and must be discarded C Cleaning the ARES Forehead Sensor Materials 1 Alcohol based hand sanitizer meeting CDC hand hygiene guidelines 2 Two 70 Isopropyl Alcohol Pads 3 Non latex or nitrile gloves Parts Reference COMPONENT DESCRIPTION 1 Luer Lock 2 Forehead Sensor 3 Forehead Se...
Page 11: ...mation on lifting the forehead sensor 4 Push down the long edge of the forehead sensor closest to the grid of speaker holes and gently lift up the other long side of the forehead sensor Thoroughly rub all exposed areas of the sensor enclosure pad underneath the forehead sensor and the underside of the forehead sensor for approximately 10 seconds Please see cautions on page 10 for information on li...
Page 12: ...nd apply a clean clear plastic cover and place the Unicorder in a clean plastic bag CAUTION Vigorous rubbing of the sensor with sufficient moisture from cleansing gel and isopropyl alcohol is required for proper cleaning Do not tug on the forehead sensor when lifting it to clean sides of sensor and sensor enclosure pad underneath forehead sensor To avoid damaging the sensor do not rub it with your...
Page 13: ...rface with the luer lock connector pointing upward 2 Place the two cannula tips in front of the ARES with the tips curving toward the device 3 Begin affixing the cannula tubing into the four cannula clips on the strap Pull down slightly on the tubing on both sides of the clip until the tubing slides into the clip 4 Attach the Nasal Cannula luer lock to the enclosure luer lock and rotate it clockwis...
Page 14: ...top flashing when charging is complete 5 If there is a problem with the charging the ARES will provide a voice message or chirp 4 times a second 6 The green indicator light on the ARES will switch off when charging is finished Remove the USB Cable from the ARES and it will shut off automatically 7 Recharge the ARES with the USB charger supplied Do not charge the ARES by connecting it to the USB por...
Page 15: ... EEG Sensor into the connector on the EEG Flex circuit Repeat for the other EEG Sensor and Flex circuit G Placing the ARES in a Clean Resealing Bag After the ARES has been cleaned the plastic sensor cover has been applied and new disposable components have been applied the ARES must be placed in a new reseal ing bag so as not to contaminate any of the ARES surfaces and to protect the silicone fore...
Page 16: ...crosoft Net 3 5 framework or higher to be installed on the system A Initiating a Study 1 The initialize device process checks the status of the device and writes some basic patient identifiers on to the device before dispensing the device to the patient 2 The device must be attached to the machine using the provided USB cable From the ARES portal main menu the user will click on the new study menu ...
Page 17: ...rap into place d Remove hair from under the sensor e Adjust the slip tube to tighten the cannula Make sure the cannula tips cannot be pulled more than 1 4 inch away from the nose f When removing the ARES gently peel the black sensor away from your forehead prior to completely removing the ARES from your head Failure to do so may damage the sensor connector Problem to avoid If the slip tube is not ...
Page 18: ...A 601 1 UL 2601 1 EN IEC 60601 1 2 2nd edition Type of protection Class II internally powered by battery Degree of protection against electrical shock Type BF Applied part Mode of operation Continuous Degree of Safety in presence of flammable mixtures UL 2601 1 sub clause 5 5 Not suitable Applied sensor label to indicate Type BF applied part IEC 60601 1 Symbol 2 of Table DII of Appendix D Attentio...
Page 19: ...16 Audio Signals and Interpretation Event Sound When audio ...
Page 20: ...assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Model 610 is used exceeds the applicable RF compliance level above the Model 610 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting...
Page 21: ... and ARES Insight are trademarks of Watermark Medical Inc Atlanta GA Windows is a trademark of Microsoft Corporation All other products or brand names are trademarks or registered trademarks of their respective companies Guidance and Manufacturer s declaration Electromagnetic Emissions PaTEnT and TRadEMaRK aCKnOWLEdGEMEnTS ...
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Page 24: ...ARES 610 PRODUCT GUIDE SM 0003 REV 07 ...
