Otsuka America Pharmaceutical 06120 Proteus Patch, Model SPC-0800 User Manual1

Proteus Digital Health, Inc. Proteus Patch, Model SPC-0800 Users Manual1

Contents

Users Manual1

CAUTIONSDO NOT continue use until further instructed by a physician if your skin is irritated or inflamed around the Patch. 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 Patch.DO NOT use if you are allergic to adhesive tape.DO NOT wear the same Patch 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 NOT store in extremely hot, cold, or humid conditions.DO check the expiration date before applying.ELECTROMAGNETIC & OTHER INTERFERENCESThe Patch has been tested and deemed in conformance with the relevant requirements in EN60601-1-2:2007 Class B for Electromagnetic Compatibility (EMC). EQUIPMENT SYMBOLS Batch code Catalogue number European Authorized Representative Manufacturer Read instructions before use Type BF applied part 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 IP27INSTRUCTIONS FOR USEProteus PatchTHE PATCHPATCH BUTTONPress and hold the patch button for 3 seconds to initiate communication to Mobile Computing Device.INDICATOR LIGHTA blinking green light indicates that communication to the Mobile Computing Device has begun.Remember: Use Mobile Computing Device to start patch changeLOTREFCAUTION: Investigational device. Limited by Federal (USA) law to investigational use.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 0086US Patent No. 8114021Made in USALBL-0170, Rev 2 | 17DEC2013IP27EC REPSPECIFICATIONSBattery Coin cellData recording time 5 – 7 daysStorage conditions Original package under normal room temperature and humidityWater resistant 1 meterEC REP
The 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 to a Mobile Computing Device and affixing the Patch to your skin. The Patch may be worn during most activities, including exercising and bathing.REPLACING A PATCH1. REMOVEPull the used Patch away from your skin. Do not discard until your new Patch is connected.2. Prepare your skin by using clippers to trim any hair from selected location. Gently pat the location you have selected with the provided alcohol wipe. Wait for your skin to dry. 3. Apply the Patcha. Remove a Patch from its pouch and peel off the first backing. Take care not to wrinkle the adhesive.b. Stand in a comfortable, upright position. With the Patch button facing upwards, apply the Patch to your selected area. c. Make sure to peel off the second backing. Then smooth the edges around the Patch with your fingers.4. DISPOSEFinally, check status of the previously removed used Patch on your Mobile Computing Device. When the data transfer is complete, dispose of the used Patch as you would any household battery or electronics (please check your local electronic waste disposal standards).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. TROUBLESHOOTINGPROBLEM The Patch feels hot.The Patch no longer sticks to your skin.The Patch is falling apart.The indicator light does not flash upon push and hold.SOLUTION Replace with a new Patch.ADDITIONAL INFORMATIONFor further instruction on troubleshooting and technical information, please visit: www.proteusdigitalhealth.com/suppinfo/ ProteusPatch.pdf2. CONNECTTurn on the Mobile Computing Device and launch application. Follow instructions in the application to connect a new Patch.3. PLACEWhen you are connected:1. Select a location on the left side of your body just above the lower edge of your rib cage (see indicated areas in figures).Avoid locations: • Where undergarments may press against the Patch.• Where your previous Patch was just removed.

Navigation menu