Delsys SP-W03 Wireless EMG Hip Module User Manual

Delsys Inc. Wireless EMG Hip Module Users Manual

Users Manual

TrignoTM Personal Monitor User’s Guide1TRIGNOTM Personal MonitorUser’s GuideOctober 2011 Edition (DRAFT)PM-W02Copyright © 2011 Delsys IncorporatedSpecications and procedures outlined in this document are subject to change without notice.Delsys Logo, EMGworks and Myo-monitor are Registered Trademarks of Delsys Incoroporated.MAN-014-1-0 (DRAFT)
2Table of ContentsImportant Information 3Intended Use 3Contraindications 3Technical Service and Support 3Warning and Precautions 4Device Information 5Disclaimer 7Limited Warranty 7System Requirements 7TrignoTM Personal Monitor Overview 8Trigno Sensor 8Body-Worn Personal Monitor 8Trigno Sensor Recharger 8
TrignoTM Personal Monitor User’s Guide3Important Information Intended Usee TrignoTM Wireless EMG Systems are designed for research, investigational and scholarship purposes only. Delsys® products are not intended for measurement purposes or for use in the treat-mentand diagnosis of humans.Rx ONLYContraindicationsDO NOT USE on Patients with implanted electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic infusion pumps, and implanted stimulators.DO NOT USE on irritated skin or open wounds.DO NOT USE on Patients with allergies to Silver.Technical Service and SupportFor information and assistance visit our web site at:www.delsys.comContact us at:tel: (617)-236-0599email: support@delsys.com
4Consult all accompanying documents for precautionary state-ments and other important information.Consult accompanying user’s guide for detailed instructions. Keep the device dry. e presence of liquids may compromise the safety features of the device.Handle with care.Sensitive electronic device. Avoid static discharges. Do not oper-ate or store near strong electrostatic, electromagnetic, magnetic or radioactive elds. Interference from external sources may de-crease the signal-to-noise ratio or result in corrupted data.Connect only to Delsys-approved devices.Connecting a patient to high-frequency surgical equipment while using Delsys EMG systems may result in burns at the site of the EMG sensor contacts.Immediately discontinue device use if skin irritation or discom-fort occurs.Immediately discontinue device use if a change in the device’s performance is noted. Contact Delsys technical support for as-sistance.Warning and Precautions
TrignoTM Personal Monitor User’s Guide5Delsys Inc. guarantees the safety, reliability, and performance of the equipment only if assembly, modications and repairs are carried out by authorized technicians; the electrical installation complies with the appropriate requirements; and the equipment is used in accordance with the instructions for use.Device contains a Lithium-Polymer battery. Do not damage, crush, burn, freeze or otherwise mishandle the device. Recharge only with the approved power supply and recharger.Trigno Systems should be stored and operated between 5 and 50 degrees Celsius due to the presence of an internal Lithium Poly-mer rechargeable cell. Storing or operating the device, and conse-quently the cell, outside of this temperature range may compro-mise the integrity and the safety features of the cell.Device InformationComplies with Requirements put forth by the Medical Device Directive 93/42/EEC. Class I device, Annex VII.Type BF device (IEC 60601-1).Isolated device, (Class II, IEC 60601-1)Do not dispose this product with house waste. Contact Delsys Inc. for instructions on responsibly disposing this device. is product should not be mixed with other commercial wastes.Date of Manufacturing (appears on device)Serial Number (appears on device)EMERGO EUROPEMolenstraat 152513 BH, The HagueThe NetherlandsAuthorized Representative ManufacturerDELSYS INC.650 Beacon St.Boston MA 02215USA
6FCC ID: W4P-SP-W03 (Trigno Body Worn Receiver)FCC ID: W4P-SP-W01 (Trigno Sensor)IC: 8138A-DST02 (Trigno Personal Monitor System)is device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) is device may not cause harmful interference. and (2) this device must accept any interference received, including interference that may cause undesired operation. is product complies with FCC OET Bulletin 65 radiation ex-posure limits set forth for an uncontrolled environment.Operation is subject to the following two conditions: (1) is device may not cause harmful interference. and (2) this device must accept any interference received, including interference that may cause undesired operation.Pursuant to Part 15.21 of the FCC Rules, any changes or modi-cations to this product not expressly approved by Delsys Inc.might cause harmful interference and void the FCC authoriza-tion to operate this product.To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotro-pically radiated power (EIRP) is not more than that required for successful communication.is 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. ese limits are designed to provide reasonable protection against harmful interference in a residential installation. is equipment generates, uses, and can radiate radio frequency en-ergy and, if not installed and used in accordance with the instruc-tions, may cause harmful interference to radio communications. ere is no guarantee that interference,will not occur in a par-ticular installation. If this equipment does cause harmful inter-ference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouragedto 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 outlet on a separate circuit.
TrignoTM Personal Monitor User’s Guide7DELSYS INC. makes no warranties, express or implied, as to the quality and performance of this product including but not limited to, any implied warranty of applicability for other than research uses by qualied individuals. DELSYS INC. shall not be liable to any person for any medical expenses or any direct or consequential damages resulting from any defect, failure or mal-function, whether a claim for such damages is based upon theory of warranty, contract, tort or otherwise. No representative, agent, or licensed practitioner is authorized to waive this disclaimer. DELSYS INC. makes no diagnosis or prescription by virtue of anything about this product.Disclaimere TrignoTM Wireless EMG Systems are warranted against failure of materials and workmanship for a period of 1 year from the date of delivery, provided that the product is given proper care and has not been subject to abuse during this period. is warranty is in lieu of all other warranties expressed or implied. Operation of this device outside specications determined by DELSYS INC. or use with any other input devices other than DELSYS INC. sensors constitute an invalidation of this limited warranty. is warranty is not transferable.Limited WarrantyEMGworks 4.0.2 or later• Windows 7, 32 bit operating systems only. Alternate OS: • Windows Vista or Windows XP with service pack 3.One USB 2.0 port• At least 2.0 GHz processor clock speed• At least 2 GB system memory• 1280x1024 (SXGA) display resolution or better• 1 GB hard disk storage• Users of Windows 7 and Vista can simply ensure that they • have a Windows Experience Index of 4.0 or greater.System Requirements
8e TrignoTM Personal Monitor is a high-performing EMG and physiological monitoring device unparalleled in its sophistication, its reliability and its ease-of-use. Each EMG sensor has a built-in triaxial accelerometer, a guaranteed transmission range of 40 m and a re-chargeable battery lasting a minimum of 7 hours. e system is capable of either logging data internally or streaming it to EMGworks®. e unit is capable of communicating with 16 Trigno sensors (resulting in 64 data channels), as well as logging GPS information and internal 3 DOF accelerometer data which has 4 selectable ranges (±1.5g, ±4g, ±6g, ±12g). Full triggering features further expand the possibility for integration with additional measurement technologies.e Personal Monitor can be used in either of two operational modes: 1) Mobile Monitoring (Figure 1A): e device acts as a wearable communicator, receiving data from wireless sensors and storing these in on-board memory to be downloaded for future analysis.2) Destktop Data Acquisition (Figure 1B): In this mode the device is connected with a USB port to a host computer and sensor data are streamed into EMGworks®for real-time viewing and analysis. is mode also allows the Personal Monitor to be congured by EMG-works® and permits stored data to be downloaded from memory.TrignoTM Personal Monitor Overview A) Mobile Monitoring, B) Desktop TransmissionFigure 1.
TrignoTM Personal Monitor User’s Guide9Trigno Sensors are equipped with the following features:transmission range of 40m• no inter-sensor latency (< 1 sample period)• self-contained rechargeable battery• EMG signal bandwidth 20- 450 Hz• EMG signal sampling rate of 2000 samples/sec• EMG baseline noise of 750 nV RMS• CMRR > 80dB• 16-bit EMG signal resolution• integrated 3DOF accelerometer (± 1.5g or ±6g)• LED User feedback• battery charge monitoring and status indicator• environmentally sealed device• proven parallel bar electrode technology• contoured sensor-skin interface for maximum signal stability• auto shuto• Wireless EMG Sensor FeaturesInertial Sensing Axis EMG ElectrodesTrigno 4-channel wireless sensor features.Figure 2. Status LED Behavior LEDData Streaming Green ash, 1HzScanning Amber/green, 1HzPairing Successful Green ash 3X, button pressedPairing Unsuccessful Red ash, 3X, button pressedBattery Charging Amber solid, in cradleCharging Complete Green solid, in cradleCharging Error LED off, in cradle with power Sensor Off LED off
10Personal Monitor Featurese Trigno Personal Monitor is equipped with the following fea-tures:support for 16 Trigno sensors (16 EMG, 48 Accelerometer)• internal 3DOF acceerometer (±1.5g, ±4g, ±6g, ±12g)• GPS capable• 16 GB memory for data storage• 8-14 hr battery life (usage dependent) • QVGA LCD display screen• Automatic DAQ protocols• Audio/Visual prompts• USB support for real-time data viewing and memory download.• sensor status feedback• charge status feedback• auto shuto• 2-hr reacharge time• NavigationButtonsSoft KeysDataPortUSB PortAudio JackPower/RechargeConnectorBattery ChargeLocal TimeMemory StatusDataPortRecharge IndicatorDataPort Personal Monitor Features.Figure 3.
TrignoTM Personal Monitor User’s Guide11Getting Started with the Personal MonitorCharging the Trigno SensorsConnect the Trigno power supply to the circular DC jack located on the side of the Recharge Station. Energize the power supply by connecting it to a Mains outlet. Be sure to use the appropriate plug adapter for your locations (Figure XX). Ensure that the Trigno sen-sors are properly tted in the recharge pockets. e sensor LEDs will illuminate to amber during charging and green when charge is com-plete. e recharge unit will periodically check sensors and apply a top-o charge to ensure that the battery kept at full capacity during extended periods of storage, as long as power is connected.Charging the Personal MonitorConnect the Personal Monitor power supply to the DC jack locat-ed on the bottom side of the device. Energize the power supply by connecting it to a Mains outlet. Be sure to use the appropriate plug adapter for your locations (Figure XX). Alternatively the Personal Monitor can be charged via the USB port, by connecting it to a host device. Checking Sensor StatusFrom the home screen, select the “Sensors” button to display the sta-tus of all active sensors. e status shows sensor charge status, channel number, sensor type, network status and wireless signal strength. Sen-sors can be paired from this screen, or turned o. Use the scroll arrows to navigate the display as needed. Checking the sensor status on the TPM.Figure 4.
12Running a TestFrom the home screen, select the “Tests” button to display a list of available data acquisition test protocols. Use the navigation keys to choose the desired Test and press the “Select” button to run it.Selecting a Test on the TPM.Figure 5. Managing Data FilesData les can be listed by selecing the “Menu” button on the home screen and then selecting “View Data Files”. A listing of the all the-stored data les on the device will be available. ese les are gen-erated by a corresponding Test le and synchronized in EMGworks. Files can be deleted to free memory on the Personal Monitor either through EMGworks or by selecting the “Delete” command on the de-vice itself. e amount of free memory is displayed at the top of the screenFile deletions on the TPM are permanent.Selecting a Test on the TPM.Figure 6.
TrignoTM Personal Monitor User’s Guide13Setting the TPM OptionsSetting the TPM Options.Figure 7. e device options can be set by selecting the Menu function from the home page, followed by the “Set-up options” function. Following options are available:Button Lock: when engaged this feature will lock all buttons on the TPM so that inadvertent button presses will have not eect on the device behaviore. e lock is released by selecting the designated 3 keys simulataneously.Alert Volume: audio prompts and alerts are accessable on the headphone port. e volume for these can be set bewteen 0 (low) to 10 (highest).Backlight Level: the screen can be set to 3 levels of brightness.Power consumption increases with screen brightness.Backlight Time-Out: when engaged, this feature will turn the screen backlight o to save battery power, aer the number of selected minutes expires.Power-Down Time: when engaged, this ll will power down the device only if it remains idle for the duration specied.Keep Sensors On: is feature will ensure that the wireless sen-sors remain turned on even when idle. When this feature is disen-gaged, the wireless sensors will turn o aer 5 minutes of inactivity.Time Format: is option species whether to display the time in 12h or 24h format.Date Format: is options species the date format presentation.
14Setting the TimeIn order to guarantee data integrity and proper le synchronization with EMG-works, it is fundamentallly important that the Personal Monitor retain accu-rate time settings during operation. e internal clock is automallicatly synchro-nized by EMGworks when the device is connected to a PC. In cases where ac-cess to a PC is restricted, it is possible to manually set the time by selecting the “Set Clock” option from the Menu op-tions.Setting the Date & TimeFigure 8.
TrignoTM Personal Monitor User’s Guide15Orienting the Sensors on the SkinTrigno EMG Sensors are tted with 4 silver bar contacts for detectinUg the EMG signal at the skin surface. It is crucial that the orientation of these bars be perpendicular to the muscle bers for maximum signal detection. e top of the sensor is shaped with an arrow to aid in the determination of this orientation. e arrow should be placed parallel to the muscle bers underneath the sensor. e sensor should also be placed in the center of the muscle belly away from tendons and the edge of the muscle. e sensor is easily attached to the skin using the Delsys Adhesive Sensor InterfaceUsing the Wireless EMG Sensorsmuscle ber directionEMG Sensors must be properly oriented with the muscle -Figure 9. bers. Align the sensor’s arrow with the direction of the underlying muscle bers.Prior to axing the EMG sensor on the surface of the skin, the sensor site must be properly cleaned to remove dry dermis and any skin oils. Wiping the skin prior to sensor application is critical. If excessive hair is present, it will also be necessary to shave the site. In cases where the skin is excessively dry, it may be useful to dislodge dry skin cells by dabbing the site with medical tape. e dry cells will attach the tape’s adhesive when it is removed. Be sure to wipe with isopropyl alcohol to remove any adhesive residue that may remain.Cleaning the Sensor SiteApplying the Sensor InterfaceTrigno System are supplied with specially-designed adhesive inter-faces to simplify sensor attachment. ese interfaces are cut from double-sided medical grade adhesive approved for dermatological applications. Usage of the interface promotes a high quality electri-cal connection between the sensor bars and the skin, minimizing mo-
16tion artifacts and the ill-eects of line interference. To ensure a strong bond with the skin, it is advised to remove excessive hair and wipe the skin area and the EMG Sensor with isopropyl alcohol to remove oils and surface residues. Allow the skin to dry completely before apply-ing the interfaces.Adhesive Sensor Interfaces are for single use only. Immediately discontinue use if skin irritation or discomfort oc-curs. All Adhesive Sensor Interfaces and Reference Electrodes are for single use only. Discard aer using. Reseal storage bag to main-tain freshnesSensor PairingTrigno sensors communicate with a custom wireless protocol that links each sensor to a Personal Monitor. is linking process is known as sensor “pairing”, and is initiated through the “Pair” command. 1. Initiate sensor pairing in soware.When using EMGworks, initiate pairing by right-clicking the Trigno hardware icon in the system notication area, and selecting the ap-propriate menu item.Selecting the Pair command form the Windows Tray Icon. Figure 10. Right click to access menu options.
TrignoTM Personal Monitor User’s Guide172. Complete the pairing process by depressing the desired sensor but-ton for a minimum of 3 seconds. Successful pairing will result in 3 green LED ashes on the sensor, and a conrmational message in the soware.Trigno systems are shipped with all sensors appropriately paired. Sen-sor pairing is typically needed if sensors are being replaced within the network group, when the communication frequency sets are changed, and aer a rmware upgrade is performed.Pushing the sensor button to complete the pairing process..Figure 11. e system stores calibration information for sensors which have been paired with it. When collecting data with EMGworks, this calibration information is used to accurately display measured values, in many cases without the need for a user-initiated manual calibration. Aer a pairing operation is completed, the system automatically searches for pre-existing factory calibration data on the particular sensor. If the sensor has never been paired with the system (for example, in the case of a new additional sensor), the soware will prompt the user to enter factory calibration data, which can be obtained from Delsys. Factory calibration data are a string a numbers and letters which encode the calibration values for a specic sensor. Factory calibrations are specic to a single sensor and will not be accepted by the soware for use on another sensor. At any time a nominal, “default” calibration may be selected for a sensor, or the specic factory calibration may be re-entered. is feature is accessed by re-pairing the sensor.Sensor Factory CalibrationFactory Calibration Prompt. e calibration can be either Figure 12. autodetected,or entered manually if the sensor is being paired for the rst time.
18Smart SensorsAer pairing, the association of sensors to the TPM is retained for all future uses. Any conguration in EMGworks can be made to reect the last paired set of sensors by clicking the “Refresh Smart Sensors” button in the “Add Sensors” pane in EMGworks. When data collec-tion starts, the soware will verify that the sensors currently commu-nicating match those used in the conguration. If there is a mismatch, cancel the recording and repair the sensors.Sensor ModesEach Trigno sensor can operate in one of 4 possible data collection modes, which determines the type of data being collected. When using EMGworks, the sensor mode can be set on the sensor settings pane for each sensor. Note that the number of modes available is de-termined by the Trigno sensor type.Setting Senosr Modes in EMGwork.Figure 13.
TrignoTM Personal Monitor User’s Guide19Maintenace and CareTrigno sensor are encased in a sealed polycarbonate enclosure. e following points should be kept in mind when handling the sensors.All sensors should be visually inspected before each use to ensure • that no mechanical deterioration has occurred. e sensors can be cleaned and sterilized with a damp cloth and • mild detergent, or with 70% isopropyl alcohol swabs. Ensure that the sensor contacts remain clean at all times for proper operation.While the sensors are sealed and are water-resistant, these should • never be completely submerged in any liquid. ey are design to be used on damp skin surfaces and in the presence of sweat without com-promise to safety, sensor integrity or operation.e sensor contacts are made of pure silver and are quite so. • Care should be taken to preserve the integrity of these contacts. Do not scrape or dent these contacts. Handle the sensors with care: do not drop them on the groun or • step on them.Smart SensorsDo not submerge the sensors in any liquid under any circum-stance.e sensors contain sensitive electronic circuitry. Static discharges and intense magnetic elds should be avoided to prevent the risk of irreparable damage to the sensors.
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