Otsuka America Pharmaceutical 01750 Electronics module for body worn personal monitors User Manual

Proteus Digital Health, Inc. Electronics module for body worn personal monitors Users Manual

Contents

Users Manual

SPECIFICATIONSBattery Coin cell Data recording time 5 - 7 daysStorage conditions Original package under normal room temperature and humidityWater Resistant 1 MeterCAUTIONSDO NOT continue use until further instruction 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 check the expiration date before applying.DO NOT store in extremely hot, cold, or humid conditions.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 Serial number 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 device to start patch changeLOTSNREFCAUTION: Investigational device.Limited by United States law to investigational use.ManufacturerProteus 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 US Patent No. 8114021Made in USALBL0093, Rev 2 17MAY2013IP27
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 PATCHTo Start...Turn on the Mobile Computing Device and lauch application. Open the Patch screen and tap “New Patch.” 1. CLEARBefore putting on a new Patch, follow the instructions on your Mobile Computing Device for clearing your used Patch.To Remove a Used Patch...Gently pull the Patch away from your skin. USEDNEW2. CONNECTAfter the data is cleared from your used Patch, your Mobile Computing Device will instruct you 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 shaded areas in figure).Avoid locations: l On your abdomen below your rib cage. l Where undergarments may press against the Patch.l Where your previous Patch was just removed.To facilitate later Patch removal, use clippers to trim any hair from your selected location.2. Prepare your skin by gently patting the location you have selected with the provided alcohol wipe. Wait for your skin to dry. Dispose of the Patch as you would any household batteries 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. ADDITIONAL INFORMATIONFor further instruction on troubleshooting and technical information, please visit: www.proteusdigitalhealth.com/suppinfo/ RP4_patch.pdf3. 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.

Navigation menu