Otsuka America Pharmaceutical 01913 Proteus Two-part patch, Model RW2 User Manual Manual Technical

Proteus Digital Health, Inc. Proteus Two-part patch, Model RW2 Manual Technical

Contents

Manual Technical

LBL-xxxx Page 1 Proteus Two-part Patch Technical description Effective: xxXXX2016 Proteus Patch Technical Description Table of Contents 1.Product Identification.......................................................................................................................................22.Manufacturer........................................................................................................................................................23.Indications for Use.............................................................................................................................................24.Description.............................................................................................................................................................25.Cautions And Warnings..................................................................................................................................36.Equipment Symbols..........................................................................................................................................47.Specifications.......................................................................................................................................................47.1.Environmental Specifications..................................................................................................................47.2.Compliance to IEC 60601-1....................................................................................................................57.3.Compliance to ANSI/AAMI EC13:2002.............................................................................................57.4.Compliance to other Standards.............................................................................................................57.5.Patch Specifications....................................................................................................................................67.6.Blueetooth Wireless Technology Specifications...........................................................................67.7.EMC Information............................................................................................................................................68.European R&TTE Declaration of Conformity....................................................................................109.FCC Declarations.............................................................................................................................................109.1.FCC Interference Statement.................................................................................................................109.2.FCC Wireless Notice.................................................................................................................................109.3.FCC Identifier................................................................................................................................................11
LBL-xxxx Page 2 Proteus Two-part Patch Technical description Effective: xxXXX2016 1. Product Identification Two-Part Patch SPC-2005, SPC-2008 The Proteus Two-Part Patch is categorized as a Class II device under The Food and Drug Administration’s regulations (in US), and as a Class IIa device, under the Medical Device Directive (in EU). 2. Manufacturer Proteus Digital Health, Inc 2600 Bridge Parkway Redwood City, CA 94065 Customer Support: +1 877 285 9803 MedPass International Ltd. Windsor House Bretforton, Evesham Worcestershire, WR11 7JJ, UK 3. Indications for Use The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor (Proteus Patch) for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications. 4. Description The two-part patch is made up of a reusable pod and a replaceable adhesive strip. The pod captures information and sends this to an app. It can be used for weeks or months at a time. The pod is worn on the torso using the adhesive strip. The strip contains a small coin cell battery to provide power to the pod, and is changed weekly for comfort and a fresh battery.
LBL-xxxx Page 3 Proteus Two-part Patch Technical description Effective: xxXXX2016 The pod measures heart rate, activity, body angle relative to gravity (body position) and the time of ingestible sensor detection. The pod is connected with a mobile device via Bluetooth®, using a mobile application (app), such as Proteus Discover. Your app will prompt you when it is time to change your patch strip. Always refer to your app when changing your strip to ensure your patch is put together correctly and connected with your mobile device. The patch can be worn at anytime and during all your regular activities, including showering, exercising and on airplanes. However, after putting on a new patch avoid showering or exercising vigorously for a few hours to allow the patch to stick properly. How long it takes for a patch to stick varies from person to person. If your patch doesn’t stick well wait a few hours longer when applying a new patch. Before placing, ensure the area of the skin is free of hair, dry, and healthy. Do not apply lotion before applying a new patch. The patch can also measure ambient temperature. It is not intended to be used as a thermometer to measure human body temperature, and should not be used to diagnose medical conditions. 5. Cautions And Warnings Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician. General  Take the ingestible sensor pill with a sufficient amount of water.  Check the component expiration dates before use.  Keep components out of reach of children.  Do not store components in extremely hot, cold, humid or bright conditions.  Do not use as sole basis for medication treatment decisions. Detection accuracy is less than 100%. Patients instructed by a physician to take an Ingestible Sensor with medication may selectively adhere to one or the other. Therefore, Ingestible Sensor data should be interpreted with caution. Physicians should discuss medication-taking history with patients prior to making medication changes.  Proteus Digital Health makes no warranty for any data or information that is collected erroneously by the ingestible sensor and/or patch, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the products as instructed. Users of the ingestible sensor and/or patch who experience clinical worsening or new clinical symptoms should seek medical attention. Healthcare providers should exercise their clinical judgment in interpreting and using any data from ingestible sensor and/or patch for clinical decision-making.  Heart rate data may not be accurate for patients with pacemakers Ingestible sensor pill  Do not chew.  Do not tamper with or place in water before ingestion.  Do not exceed 30 ingestions per day. Two-part patch
LBL-xxxx Page 4 Proteus Two-part Patch Technical description Effective: xxXXX2016  Do not continue use until further instructed by a physician if your skin is irritated, inflamed, or red 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 patch.  Do not use if you are allergic to adhesive tape.  Do not drop or bump with excessive force.  Do not use to diagnose heart-related conditions.  Do not wear during magnetic resonance imaging (MRI), cautery and external defibrillation procedures.  Do not dispose of strips with household waste  Do not throw out the pod: keep if for use with your next strip  Pod may pose a choking hazard to children under 3 years of age.  Patch does not contain medication.  The device contains no serviceable parts or components  Replace the strip about once per week or as prompted by mobile app. Warning: No modification of this equipment is allowed. Modifying the Proteus Patch may cause a safety hazard for the user. 6. Equipment Symbols Batch code Serial number Catalog 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-DD Do not dispose with household waste Ingress protection rating of IP27 General warning 7. Specifications 7.1. Environmental Specifications Temperature: Operating, Patch: +5°C – +40°C - +41°F – 104°F Storage/Transportation, Pod -25°C – +70°C - -13°F – +158°F Storage/Transportation, Strip +5°C – +27°C - +41°F – +80.5°F
LBL-xxxx Page 5 Proteus Two-part Patch Technical description Effective: xxXXX2016 Short tern (< 30 days) Storage/Transportation, Strip +0°C – +40°C - +32°F – 104°F Humidity Operating, Patch: 15% - 93% (non condensing) Storage/Transportation, Pod 15% - 93% (non condensing) Storage/Transportation, Strip 15% - 93% (non condensing) Altitude Operating, Patch 700 hPa – 1060 hPa 7.2. Compliance to IEC 60601-1 The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable requirements of: IEC 60601-1 2005 IEC 60601-1-2 2014 IEC 60601-1-11 2010 Degree of Protection: Type BF applied Part Protection against Electrical Shock Internally powered medical equipment Mode of Operation Continuous Enclosure degree of Ingress Protection IP27 (water proof to 1m – 3.3 feet) IP27 Essential Performance: The essential performance of this device is defined as biocompatibility of the patch materials, as established by compliance to the ISO 10993 series of standards Use Environment The Proteus Two-part Patch is intended to be used in the Home Healthcare environment 7.3. Compliance to ANSI/AAMI EC13:2002 The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable requirements for heart rate meters of ANSI/AAMI EC13:2002 Cardiac monitors, hear rate meters, and alarms Heart Rate range: 30 to 250 bpm Heart Rate averaging: Averaged over 14 seconds Heart Rate response time: Up to 5 mins, depending on patch operating mode Response to Irregular Rythms: Ventricular Bygeminy (VB) 80 bpm Slow Alternating VB 60 bpm Rapid Alternating VB 120 bpm Bidirectional Systole 90 bpm Pacemaker pulse rejection Heart rate data may not be accurate for patients with pacemakers 7.4. Compliance to other Standards  The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable requirements of ISO 10993-1-2009, ISO 10993-5-2009, ISO-10993-10-2010 (Biological evaluation of medical devices)  The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable requirements of JIS S7200 Pedometers
LBL-xxxx Page 6 Proteus Two-part Patch Technical description Effective: xxXXX2016  This product complies with all applicable provisions of the EU Restriction of Hazardous Substances directive (RoHS)  This product complies with all applicable provisions of the EU Medical Device Directive (MDD)  The pod and strip do not contain natural latex rubber  Strip and Pod packaging materials meet the meet transit requirements per ASTM D4169, distribution cycle 13, Assurance Level II. 7.5. Patch Specifications Battery (in strip) CR2016 Lithium Manganese DiOxide coin cell (3V) Battery capacity Sufficient for at least 7 days of use Patch memory capacity Sufficient for at least 14 days of continuous recording w/o uploads 7.6. Blutooth® Wireless Technology Specifications Compliance Version 4.0 single mode low energy Operating Frequency 2.4 to 2.4835 GHz Output Power TX: -15dBm (P=0.03125mW) Effective Bandwidth 1.25 MHz Modulation Frequency hopping using GFSK (Gaussian Frequency Shift Keying) 7.7. EMC Information RF Emissions CISPR 11 Group 1 RF Environment CISPR 11 Class B RF Interference Immunity IEC 61000-4-3 Level 3 ESD Discharge Immunity IEC 61000-4-2 Level 4 The two-part Patch uses RF energy for its internal function. Its RF emissions are however very low and are not likely to cause any interference in nearby electronic equipment. This device is suitable for use in all establishments, including domestic. The device should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. The use of accessories, sensors, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The patch needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. WARNING: Portable and mobile RF communications equipment can affect the Patch. Portable and mobile F communications equipment (including peripherals such as antenna cables and external
LBL-xxxx Page 7 Proteus Two-part Patch Technical description Effective: xxXXX2016 antennas) should be used no closer than 30 cm (12 inches) to any part of the Patch. Otherwise, degradation of the performance of the Patch could result. Guidance and manufacturer’s declaration –electromagnetic emissions The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of Proteus Patch should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The Patch uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Patch is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Guidance and manufacturer’s declaration –electromagnetic immunity The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Patch should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 +/- 8kV contact +/- 15kV air +/- 8kV contact +/- 15kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient / burst IEC 61000-4-4 +/- 2 kV for power supply lines +/- 1 kV for input/output lines Not applicable Surge IEC 61000-4-5 +/- 1 kV line(s) to line(s) +/- 2 kV line(s) to earth Not applicable
LBL-xxxx Page 8 Proteus Two-part Patch Technical description Effective: xxXXX2016 Guidance and manufacturer’s declaration –electromagnetic immunity Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Not applicable Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30A/m 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration –electromagnetic immunity The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Proteus Patch should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 10V/m 80 MHz to 2,5 GHz Not Applicable 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the Proteus Patch, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Not Applicable d = 1,17 √P 80 MHz to 800 MHz d = 2,33 √P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the
LBL-xxxx Page 9 Proteus Two-part Patch Technical description Effective: xxXXX2016 recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a 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. If the measured field strength in the location in which the Proteus Patch is used exceeds the applicable RF compliance level above, the Proteus Patch should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Proteus Patch. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the Proteus Patch The Proteus Patch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Patch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Proteus Patch as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz d = 1,2 √P 80 MHz to 800 MHz d = 1,2 √P 800 MHz to 2.5 GHz d = 2,3 √P 0.01 Not applicable 0.1 0.23 0.1 Not applicable 0.4 0.74 1 Not applicable 1.2 2.3
LBL-xxxx Page 10 Proteus Two-part Patch Technical description Effective: xxXXX2016 10 Not applicable 3.7 7.4 100 Not applicable 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 8. European R&TTE Declaration of Conformity Hereby, Proteus® Digital Health, Inc., declares that the Proteus two-part Patch is in compliance with the essential requirements and other relevant provisions of R&TTE (Radio and Telecommunications Terminal Equipment) Directive 1999/5/EC. The product is compliant with the following standards and/or other normative documents:Safety (art. 3.1a): EN 60601-1, 3rd Ed, IEC 60601-1-11EMC (art. 3.1b): EN 301 489-17 v2.2.1Spectrum (art. 3.2): EN 300 328 v1.8.1Other: EN 60601-1-2 (2014) The Proteus two-part Patch can be used in all countries in the European Union. 9. FCC Declarations 9.1. FCC Interference Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Proteus Digital Health could void your authority to operate the equipment. 9.2. FCC Wireless Notice This product emits radio frequency energy, but the radiated output power of this device is far below the FCC radio frequency exposure limits. Note:
LBL-xxxx Page 11 Proteus Two-part Patch Technical description Effective: xxXXX2016 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: — Reorient or relocate the receiving antenna. — Increase the separation between the equipment and receiver. — Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. — Consult the dealer or an experienced radio/TV technician for help. 9.3. FCC Identifier FCC ID: X7901913

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