User Manual
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| Document ID | 2912024 |
| Application ID | sMD/BltnX8wCJJoli2wsrw== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 111.59kB (1394903 bits) |
| Date Submitted | 2016-02-25 00:00:00 |
| Date Available | 2016-06-24 00:00:00 |
| Creation Date | 2017-11-19 00:52:41 |
| Producing Software | GPL Ghostscript 9.18 |
| Document Lastmod | 2017-11-19 00:52:41 |
| Document Title | User Manual |
| Document Creator | Microsoft® Word 2013 |
| Document Author: | AJ Aranyosi |
BioStampRCTM User Manual PL-0036 Revision B DRAFT BioStampRCTM User Manual Revision B DRAFT Copyright 2016 MC10, Inc. www.mc10inc.com BiostampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Table of Contents 1. Welcome ......................................................................................................................................................... 3 1.1. Intended Use ............................................................................................................................................. 5 1.2. Safety Notices .......................................................................................................................................... 5 2. Getting Started ................................................................................................................................................ 7 3. BioStampRC Hardware .................................................................................................................................. 7 3.1. Sensors ..................................................................................................................................................... 8 3.1.1. Inspect and Clean Sensors ................................................................................................................ 9 3.1.2. Power On and Power Off .................................................................................................................. 9 3.2. Charging ................................................................................................................................................... 9 3.3. Sensor Application ................................................................................................................................. 10 3.3.1. Applying Sensors to Subjects ......................................................................................................... 11 3.3.2. Removing Sensors from Subjects ................................................................................................... 12 3.4. Tablet...................................................................................................................................................... 12 3.5. Wear Locations ...................................................................................................................................... 12 3.5.1. Recording Modes ............................................................................................................................ 13 4. Technical Specifications ............................................................................................................................... 14 5. Troubleshooting ............................................................................................................................................ 15 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT 1. Welcome The BioStamp Research ConnectTM system (also known as the BioStampRCTM system) is an incredibly wearable, easy to use biometric sensing platform. With the tools provided, you can go from a study concept to collecting data in just a few minutes. This powerful system also helps you organize and analyze your data, freeing you to spend more time doing research. Thin, body-conforming BioStampRCTM Sensors can be placed nearly anywhere on the body to capture accelerometer, gyroscope, and surface biopotential signals which can be used to measure body motion, muscle, and heart activity. The Sensors adhere directly to the skin, capturing biometrics of targeted body locations. Because the Sensors store data locally, your subjects are free to move normally in natural environments. This manual provides an introduction to help you understand the capabilities of your BioStampRC system, and provides necessary information for configuring and operating your BioStampRC system. The latest version of this manual is available at the MC10 web site. For support, service, maintenance or further information on this product contact the manufacturer: MC10, Inc. 10 Maguire Rd., Building 3, Floor 1, Lexington, MA 02421, USA Phone: Fax: +1 (857) 214-5600 +1 (781) 538-6641 Web: Email: www.mc10inc.com BioStampRCsupport@mc10inc.com www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT FCC Compliance Notification The BioStampRC Sensors and the included wireless charger have been found to satisfy the FCC radiation exposure limits set forth in Part 2 of the FCC’s Rules for portable devices operating in an uncontrolled environment. To ensure exposure to RF radiation falls below those limits during operation, users must follow the specific operating instructions for these devices and must not co-locate or operate these devices with any other antenna or transmitter. The BioStampRC Sensors comply with Part 15 of the FCC Rules. The included wireless Charger complies with Part 18 of the FCC Rules. Operation of each device 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. NOTE: The BioStampRC Sensors have 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. The included wireless battery charger has been tested and found to comply with the applicable limits under Part 18 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference to licensed radio services. However, the charger 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. 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, or to another authorized radio service, which can be determined by turning the charger off and on, the user is encouraged to try to correct the interference by one or more of the measures described immediately above. CAUTION: Changes or modifications to either the Sensors or the included charger not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Responsible Party: MC10, Inc. Phone: +1 (857) 214-5600 Fax: +1 (781) 538-6641 Web: Email: www.mc10inc.com BioStampRCsupport@mc10inc.com www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT NOTE: This device complies with Industry Canada’s licence-exempt RSSs. Operation is subject to the following two conditions: (1) This device may not cause interference; and (2) This device must accept any interference, including interference that may cause undesired operation of the device. AVIS : Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) l’appareil ne doit pas produire de brouillage; (2) l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. 1.1. Intended Use The BioStampRC system is designed to collect certain physiological data in research studies. The system is intended to capture raw data about movements and biopotentials. The data collected by the BioStampRC system can provide quantifiable analysis of physical motion and electrophysiology. BioStampRC Sensors are research tools and are not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease or condition in humans or animals. 1.2. Safety Notices Carefully read this manual before using the BioStampRC system. BioStampRC Sensors and adhesive stickers are non-sterile. Adhesive stickers are for a single use on a single subject. BioStampRC Sensors are only for use on intact, unbroken and non-diseased skin. Upon BioStampRC Sensor removal, slight redness of skin may be observed and is typically resolved within 2 days. If serious skin reactions occur, discontinue use of BioStampRC Sensors on that person. BioStampRC Sensors may be susceptible to RF interference from other equipment used in their vicinity. BioStampRC Sensors are water resistant up to 1 m depth. Long term immersion in fluids may permanently damage the BioStampRC Sensors. Dry Sensors immediately after exposure to fluids. BioStampRC Sensors have not been tested on individuals who have a pacemaker or other sensitive medical device. To the extent that you opt to include individuals with pacemakers or other sensitive medical devices in any Study, you agree to instruct the individual to speak with his/her doctor before wearing the BioStampRC Sensors and obtain confirmation of the same. In addition, you must obtain informed consent from the individual indicating that the individual has been advised that the product has not been tested on individuals with pacemakers or other sensitive medical devices and agrees to participate anyway. BioStampRC Sensors have not been tested on pregnant women. To the extent that you opt to include pregnant women in any Study, you agree to instruct the individual to speak with her doctor before wearing the BioStampRC Sensors and obtain confirmation of the same. In addition, you must obtain informed consent from the individual indicating that the individual has been advised that the product has not been tested on pregnant women and agrees to participate anyway. You agree to assume all liability relating to any claims brought by individuals who have pacemakers or other sensitive medical devices or women who wore the device while pregnant. www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Individuals having an allergy to adhesives or silicone should not wear the BioStampRC Sensors. You agree to assume all liability relating to any claims brought by individuals who have an allergy to adhesives or silicone who wore the BioStampRC Sensors. Data privacy: data captured and provided by BioStampRC Sensors is not automatically anonymized, encrypted, or otherwise privacy-protected. It is your responsibility to assume any data security and privacy risks and to convey these risks to your subjects. Modification or disassembly of BioStampRC Sensors or chargers poses a risk of electric shock. Do not use BioStampRC Sensors or chargers if internal circuitry is exposed or encapsulation is compromised in any way. BioStampRC systems that have reached end-of-life should be disposed of properly. BioStampRC Sensors are rechargeable electronic units that contain lithium-polymer batteries. Such batteries are classified as hazardous substances in certain jurisdictions, and should be disposed of according to local laws and regulations. www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT 2. Getting Started The best way to get started with the BioStampRC system is to follow the Quick Start Guide available at http://www.mc10inc.com/ and included in your kit. The Quick Start Guide walks you through the process of applying the Sensors, capturing and downloading data, and completing Activities and Diaries using an example Study. This process will show you how the different system components work together. Later, you can use the Investigator Portal to design your own Studies. 3. BioStampRC Hardware Figure 1 shows a representative BioStampRC system. The pictured configuration has 3 Sensors, 21 adhesives, conductive gel, a single charger, and a single tablet. This configuration is sufficient for a 7-day study with three Subjects wearing one Sensor each, or one Subject wearing three Sensors. The number of Sensors, adhesives, chargers, and tablets in the system can vary based on the size of your study. Figure 1. Example contents of a BioStampRC System. www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT In general, each BioStampRC kit contains one or more: BioStampRC Sensors (Model BRCS01) Single-unit Chargers (Model BRCC01) Adhesive packs Tubes of conductive gel Tablet with AndroidTM and the BioStampRC Investigator App Quick Start Guide This User Manual Other system components, such as the Investigator Portal, are available at the MC10 web site. 3.1. Sensors The BioStampRC Sensor is an extremely thin, skin-wearable system designed to measure and record biometric signals. The Sensor is optimized for small size and low power operation. The Sensor contains the following sensing modules: Low-power 3-axis accelerometer (±2, 4, or 8 G range; 50, 100, or 200 Hz sample rate; 12 bit operation) High-range 6-axis gyroscope + accelerometer (±250, 500, 1000, 2000°/sec gyroscope range; ±2, 4, 8, or 16 G accel range; 25, 50, 100, 250 Hz sample rate; 16 bit operation) Analog front end (AFE) for sEMG and electro-cardiac activity measurement (±0.2V range at the electrodes; 125 and 250 Hz sample rate; 16 bit operation) In addition, the Sensor has a microprocessor, Bluetooth® Smart connectivity, 32 MB of low-power, nonvolatile memory, and a 15 mAh rechargeable battery with wireless inductive charging capability. The BioStampRC Sensor is shown in Figure 2, with the sensing axes for reference. Figure 2. BioStampRC Sensor coordinate system. The Sensor axes are as shown in the diagram. The BioStampRC Sensor can be placed in various body locations, and multiple Sensors can be placed on a single person. Once configured using the Investigator App, the Sensor operates independently, storing data in www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT its local memory. The data can then be transferred wirelessly for display and subsequent analysis. The BioStampRC Sensor is designed for use cases involving up to 24 hours of continuous wear. 3.1.1. Inspect and Clean Sensors Inspect all Sensors for damage prior to use. Damage includes cracked, split, or broken encapsulation; exposed electronics other than the electrodes; tears or splits in the device; or any other deviation from the manufactured state that might impair functionality. Do not use Sensors that have visible damage. BioStampRC Sensors are shipped clean, and do not require cleaning before use. If you remove a Sensor from a subject and plan to replace it later, clean the Sensor before re-use. We recommend cleaning the Sensor prior to recharging. To clean, simply remove and dispose of the adhesive sticker, wash the Sensor by hand with soap and water, and pat dry. BioStampRC Sensors tolerate exposure to 70% isopropyl alcohol. The adhesives may interact with residual alcohol, however. Be sure to allow alcohol-exposed Sensors to dry thoroughly before applying adhesives. DO NOT expose Sensors to heat above 60°C, dishwashers, clothes dryers, autoclaves, or other industrial cleaning processes. 3.1.2. Power On and Power Off BioStampRC Sensors are shipped in a powered-off state. To power them on, simply place the Sensor on the charger as shown in Figure 3. Be sure to align the logo on the Sensor with that on the charger, and place the Sensor within the outline on the charger. When the Sensor is powered on, a green light in the lower right corner of the Sensor blinks intermittently. Every ten seconds, the light will rapidly blink twice. Watch for this light to verify that the Sensor is powered on. For long-term storage, Sensors should be powered off. Sensors can be powered off using the Investigator App. Consult the BioStampRC Software Manual for details. If the Sensor is on a charger, powering it off will have no effect. 3.2. Charging BioStampRC Sensors are equipped with a rechargeable battery. The Charger included with your kit is designed to recharge the Sensors wirelessly. The Charger is designed to be plugged into the included voltage adapter. A suitable power outlet must be available near the location of installation and be easily accessible. www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Figure 3. (Left) Single-unit Charger. (Center) The charging light at the bottom comes on when a Sensor is placed on the Charger. Note the alignment of the Sensor logo with the logo printed on the Charger. (Right) Charging light blinking patterns. When the Charger is plugged into a wall outlet, the power light in the upper left corner comes on (Figure 3, Left). The charging light near the bottom of the charger should be off. If this light is blinking rapidly (Figure 3, Right), the charger experienced an error and must be restarted. Place a Sensor on the Charger to charge it, being sure to align the logos as shown (Figure 3, Center). The charging lights at the bottom of the Sensor should pulse slowly while the Sensor is charging. When the Sensor is fully charged, the charging lights will stay on. To check the current charging state of the Sensors, use the Investigator App. The BioStampRC charger is designed for indoor use only. Connect the charger to the included adapter and plug it into a wall outlet. The charger is designed for use at 20-40 °C. Clean the charger as needed with 70% isopropyl alcohol or soap and water. No other maintenance is required. 3.3. Sensor Application Sensors are applied to the body using disposable adhesives for attachment and conductive gel for the electrodes. Adhesives come in packs of 7 or 21. These double-sided adhesives have an opaque liner on one side and a clear liner on the other. The side with the shiny liner adheres to the Sensor, while the side with the clear liner adheres to the skin. The adhesives and liners have holes to allow electrodes on the Sensor to contact the skin. To use the adhesives, first place the Sensor electrode-side up on a flat surface. Remove the opaque liner and lower the newly-exposed adhesive surface onto the Sensor, pressing firmly for ten seconds. Make sure the electrodes are exposed through the holes in the adhesive (Figure 4). The bond between the Sensor and adhesive will grow stronger over the next few minutes. Meanwhile, apply conductive gel to the electrodes as described in the next paragraph. 10 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Figure 4. Sensor application. Top Left: remove opaque liner from Sensor side of adhesive. Top right: place adhesive on electrode side of Sensor. Bottom left: after applying gel (see Figure 5), remove clear liner. Bottom right: Place Sensor on skin and apply firm pressure. The BioStampRC system comes with a tube of conductive gel for use in facilitating electrode measurements. The use of this gel is essential for obtaining the highest quality electrical signals from the BioStampRC system. Apply a small amount to each electrode as shown in Figure 5. Only a thin coating is needed; wipe off any excess gel. Excessive use of gel may adversely affect Sensor adhesion. Figure 5. Electrodes after applying conductive gel. The gel gives the electrodes a shiny appearance. 3.3.1. Applying Sensors to Subjects This process should be done in conjunction with performing a Study using the Investigator App. It is essential to note the ID of the Sensor applied to each body location. The Sensor ID is visible on the front of each Sensor. 11 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT 3.3.1.1. Prepare Skin Proper skin preparation improves Sensor adhesion and signal quality. Before applying the Sensor, prepare the skin of the subject: 1. Choose the location to apply the Sensor. 2. Trim any excess hair at the Sensor application site. Shaving is not required and may at times impair comfort. 3. Clean the site thoroughly with soap and water, a non-alcohol wipe, or a 4 x 4 gauze pad. Alcohol wipes are not recommended as they dry the skin, which reduces adhesion and electrode signal quality. 4. Dry the skin vigorously. 3.3.1.2. Apply Sensor 1. Remove the Sensor and adhesive from the clear liner. Be careful not to touch the adhesive or electrodes. 2. Place the Sensor in the chosen location, being careful to use the same location and Sensor orientation for each subject. 3. Apply firm pressure to the Sensor for at least 10 seconds. The Sensor should stay in place by itself. If necessary, it can be secured by a secondary method such as an adherent wrap or tape. 3.3.2. Removing Sensors from Subjects To remove Sensors, simply grab them from the thicker end and peel the Sensor and adhesive off of the subject. The Sensor and adhesive should peel off cleanly. Adhesive residue on the subject can be removed with baby oil or alcohol-based solvents. Remove the adhesive from the Sensor by peeling it away, starting from the thicker part of the Sensor. Dispose of the adhesive after use. 3.4. Tablet The BioStampRC system comes with a tablet running the Android operating system. This tablet comes with the Investigator App pre-installed. For full functionality, the tablet must be connected to a WiFi network and have Bluetooth turned on. The BioStampRC User account on the tablet allows you to control these settings in addition to running the Investigator App. If the tablet asks for a PIN, tap on the BioStampRC User icon in the upper right to switch to the correct account. 3.5. Wear Locations Figure 6 shows some examples of recommended body locations for BioStampRC Sensors. This list is updated as new locations are validated. For most locations, Sensors can be placed on either side of the body. We recommend placing Sensors horizontally on trunk locations, and vertically on limbs. Consult Figure 2 for Sensor reference orientations, and choose a consistent placement location and orientation for all subjects. 12 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Figure 6. Example body locations for Sensors. This is not intended to be a comprehensive list. Locations that are not on the list are not recommended. In particular, Sensors will not adhere properly to bony joints such as knees and elbows. 3.5.1. Recording Modes The BioStampRC Sensor has multiple sensing modes with differing functionality. Different modes use different combinations of a three-axis accelerometer, a six-axis accelerometer+gyroscope, and a singlelead (two-electrode) analog voltage sensor. Table 1 lists the supported recording modes. The recording lifetime depends on both the recording mode and sampling rate chosen. Table 1. Recording modes supported by BioStampRC Mode Sampling Rate Dynamic Range Accelerometer ECG EMG Accel+ECG 50, 100, 200 Hz 125, 250 Hz 250 Hz 50 Hz (accel) 125, 250 Hz (ECG) 50 Hz (accel) 250 Hz (EMG) ±2, ±4, or ±8 G ±0.2 V ±0.2 V ±2, ±4, or ±8 G (accel) ±0.2 V (ECG) Accel+EMG ±2, ±4, or ±8 G (accel) ±0.2 V (ECG) Recording Time (Approximate) 8-35 hours 17-35 hours 17 hours 11-22 hours 11 hours 13 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT Gyro+Accel 25, 50, 100, 250 Hz ±2, ±4, ±8, ±16 G (accel) Off, ±250, ±500, ±1000, ±2000 °/sec (gyro) 2-4 hours 4. Technical Specifications Figure 7 shows the technical specifications of the BioStampRC Sensors (FCC ID 2AGYUBRCS01). Figure 7. Technical specifications for the BioStampRC Sensors. The technical specifications for the charger are listed below. Table 2. Charger specifications. Dimensions Weight Material Cable Length Certifications Power Charging Frequency IEC Protection Class 8.6 x 5.5 x 1.1 cm (LxWxH) 48.5 g Polycarbonate with Clear Coat 150 ± 1.2 cm FCC Part 18 Declaration of Conformity and UL/CSA 60950-1 5V DC, 1A 13.56 MHz II 14 www.mc10inc.com BioStampRCsupport@mc10inc.com BioStampRCTM User Manual PL-0036 Revision B DRAFT 5. Troubleshooting 1. My Sensors are not charging. • Make sure the Charger is plugged into a wall socket using the provided adapter. One power light comes on when the Charger is correctly powered. • Align the Sensor with the outline on the charger. Make sure the orientation matches. When the Sensor is correctly aligned, the charging lights on the Charger should pulse slowly. 2. My Charger has quickly blinking lights. • The Charger is designed for use with the provided adapter. Do not use it with any other adapter, or with any other electronic system having USB ports. 3. Some of my Sensors don’t show up on the list. • Power on the Sensors before use by placing them on the charger. 4. The electrical signal looks noisy. • The provided gel is required to ensure good electrical contact for bioelectric signal recording. 5. My Sensors keep falling off. • The adhesives provided with the BioStampRC system are intended for single-day use while performing typical life activities. Vigorous activities may require additional methods of securing the Sensors (tapes, wraps, etc.). 6. My Sensors cause mild redness after multiple days of wear. • Skin sensitivity varies widely among wearers. Mild redness may occur for some Subjects, but is typically not harmful. If Subjects experience significant irritation, discontinue use of BioStampRC Sensors on those Subjects. 7. Other questions? • Please contact MC10, Inc. for support at BioStampRCsupport@mc10inc.com or 857-214-5630. AndroidTM and Bluetooth® are trademarks of their respective owners. 15 www.mc10inc.com BioStampRCsupport@mc10inc.com
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