Otsuka America Pharmaceutical 06550 Proteus Wearable Sensor Module, Model SPC-0655 User Manual 1

Proteus Digital Health, Inc. Proteus Wearable Sensor Module, Model SPC-0655 Users Manual 1

Contents

Users Manual 1

SPECIFICATIONSBattery __________________________________________________________ Coin cell Data recording time ____________________________________________ 30 daysStorage conditions __________________________Original package under normal room temperature and humidityWater Resistant __________________________________________________ 1 MeterCAUTIONSDO NOT continue use until further instructed by a physician if your skin is irritated or inflamed around the replaceable adhesive strip. DO NOT place in locations where your skin is scraped, cracked, inflamed, or irritated. DO NOT place in a location that overlaps the area of the most recently removed replaceable adhesive strip.DO NOT use if you are allergic to adhesive tape.DO NOT wear the same replaceable adhesive strip for longer than one week.DO NOT drop or bump with excessive force.DO NOT use to diagnose heart-related conditions.DO NOT wear during airplane travel.DO NOT wear during magnetic resonance imaging (MRI), cautery, and external defibrillation procedures.DO check the expiration date before applying.DO NOT store in extremely hot, cold, or humid conditions.CAUTION: Patch pod is a choking hazard.ELECTROMAGNETIC & OTHER INTERFERENCESThe Patch has been tested and deemed in conformance with the relevant requirements of EN60601-1-2:2007 Class B for Electromagnetic Compatibility (EMC). EQUIPMENT SYMBOLS Batch code Serial number Catalogue number European Authorized Representative Manufacturer Read instructions before use Emits radio waves Single use only Temperature range Humidity range Atmospheric Pressure range Use by yyyy-mm Do not dispose with household waste Ingress Protection rating of IP27 General warningINSTRUCTIONS FOR USEProteus Patch — Extended UseTHE PATCHPATCH BUTTONPress and hold the patch button for 3 seconds to initiate communication to Mobile Computing Device.Contains electronics. Contains skin electrodes. Must be used with Patch pod.INDICATOR LIGHTA blinking green light indicates that communication to the Mobile Computing Device has begun.Remember: Use mobile device to start Patch pod changeLOTSNREFCAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.Proteus Digital Health2600 Bridge Pkwy, Suite 101Redwood City, CA 94065Ph: +1-650-632-4031Proteus Digital Health UK Ltd.6th Floor, 41 - 44 Great Queen St.London WC2B 5AD 0086 US Patent No. 8114021Made in USALBL-0140, Rev 2 | 19SEP2013IP27EC REPEC REPPATCH POD REPLACEABLE ADHESIVE STRIP!COMPATIBLE WITH:Replaceable Adhesive Strip (SPC-0656)
PATCH MAINTENANCEHigh levels of activity and water exposure (e.g. showering, bathing, or swimming) may cause the Patch to peel off. To help the Patch remain attached, wait at least one hour after applying the Patch before exercising or exposing it to water. When you do exercise or get the Patch wet, you should pat the Patch dry and gently run your fingers along the adhesive to prevent peeling. ADDITIONAL INFORMATIONFor further instruction on troubleshooting and technical information, please visit: www.proteus.com/suppinfo/ ProteusPatch_ExtendedUse.pdfThe Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics (heart rate, activity, body angle, and time-stamped patient logged events). Installation involves connecting the Patch pod to a Mobile Computing Device and affixing it to your skin using a replaceable adhesive strip (strip). The Patch may be worn during most activities, including exercising and bathing.REPLACING A STRIP weekly1. REMOVEGently press in the middle of the strip to release the Patch pod. Set it aside for the final step. Pull the used strip away from your skin and discard.2. CHOOSESelect a location on the left side of your body just above the lower edge of your rib cage (see shaded areas to right).Avoid locations Where undergarments may press against the Patch Where your previous Patch was just removedTo facilitate later Patch removal, use clippers to trim any hair from your selected location.REPLACING A PATCH POD monthly1. REMOVEGently press in the middle of the strip to release the used Patch pod. Do not discard your used Patch pod yet. 2. CONNECTTurn on the Mobile Computing Device and launch application. Open the Patch screen and tap “New Pod.” Follow instructions on your Mobile Computing Device to connect a new Patch pod.3. ATTACHPress the Patch pod into theframe of the strip until you hear it click. DI4. DISPOSECheck status of the used Patch pod. When the data transfer is complete, dispose of the used Patch pod as you would any household battery or electronics (please check your local electronic waste disposal standards).3. PLACEGently pat your skin at the selected location with the provided alcohol wipe. Wait for your skin to dry.Peel off the first backing from a strip. Take care not to wrinkle the adhesive.Stand in a comfortable, upright position. Orient the strip horizontally and apply to your selected location. Remove the second backing, and smooth the strip with your fingers.4. ATTACHPress your Patch pod into the frame on the strip until you hear it click.

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