Delsys SP-W02 Base Unit for Wireless EMG Sensor System User Manual

Delsys Inc. Base Unit for Wireless EMG Sensor System Users Manual

Users Manual

TRIGNOTM Wireless System User’s GuideFeb. 2009 Edition Copyright © 2009 by Delsys IncorporatedSpecifications and procedures outlined in this document are subject to change without notice.Delsys Logo, EMGworks, and Myomonitor are Registered Trademarks of Delsys Incorporated.MAN-012-1-0
1Table of ContentsTable of Contents .............................................................. 1Important Information ....................................................... 3Intended Use .......................................................................... 3Contraindications.................................................................... 3Technical Service and Support............................................... 3Warnings and Precautions...................................................... 4Device Information.................................................................. 5Disclaimer............................................................................... 7Limited Warranty..................................................................... 7TrignoTM Wireless EMG System...................................... 8TrignoTM System Components........................................ 9Wireless EMG Sensor ............................................................ 9Sensor LED Indicator Status ...................................................... 9Base Station ......................................................................... 10Power Supply........................................................................ 10Sensor Adhesive Skin Interfaces.......................................... 11Getting Started with the TrignoTM System................... 12Powering the Base Station ................................................... 12Charging the Sensors........................................................... 12Turing the Sensor ON........................................................... 12Using EMGworks with the TrignoTM System ....................... 13Using the Wireless EMG Sensors ........................................ 14Orienting the EMG Sensors on the Skin................................... 14Using the Delsys Adhesive Sensor Interface ........................... 15Maintenance and Care..................................................... 16Trigno Sensors ..................................................................... 16Recharging Base Station...................................................... 16Specifications .................................................................. 18Trigno Sensors ..................................................................... 18Trigno Recharging Base Station........................................... 19
2 Trigno Wireless System User’s Guide
3Important InformationIntended UseThe TrignoTM Wireless EMG Systems are designed for research,investigational and scholarship purposes only. Delsys® productsare not intended for measurement purposes or for use in thetreatment and diagnosis of humans. Rx ONLYContraindicationsTechnical Service and SupportFor information and assistance visit our web site at:www.delsys.comContact us at:E-mail: support@delsys.comtel: (617) 236 0599DO 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.
4 Trigno Wireless EMG System User’s GuideTMWarnings and PrecautionsConsult all accompanying documents for precautionary statements and other important information.Consult accompanying user’s guide for detailed instructions.Keep the device dry. The presence of liquids may compromise the safety features of the device.Handle with care.Sensitive electronic device. Avoid static discharges. Do not operate or store near strong electrostatic, electromagnetic, magnetic or radioactive fields. Interference from external sources may decrease 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 discomfort occurs.Immediately discontinue device use if a change in the device’s perfor-mance is noted. Contact Delsys technical support for assistance.Delsys Inc. guarantees the safety, reliability, and performance of the equipment only if assembly, modifications 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 Polymer rechargeable cell. Storing or operating the device, and consequently the cell, outside of this temperature range may compromise the integrity and the safety features of the cell.
5Device 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. This product should not be mixed with other commercial wastes.Date of Manufacturing (appears on device)Serial Number (appears on device) FCC ID: W4P-SP-W02 (Trigno Base Station)FCC ID: W4P-SP-W01 (Trigno Sensor)IC: 8138A-DST01 (Trigno System)This device complies with Part 15 of the FCC Rules. Operation is sub-ject 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.This product complies with FCC OET Bulletin 65 radiation exposure limits set forth for an uncontrolled environment.Changes not expressly approved by Delsys Inc.could void the User’s authority to operate the equipmentREPECEMERGO EUROPEMolenstraat 152513 BH, The HagueThe NetherlandsDELSYS INC.650 Beacon St.Boston MA 02215USAAuthorized Representative Manufacturer
6 Trigno Wireless EMG System User’s GuideTMTo reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radi-ated power (EIRP) is not more than that required for successful commu-nication.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. 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 outlet on a separate circuit.
7DisclaimerDELSYS INC. makes no warranties, express or implied, as tothe quality and performance of this product including but notlimited to, any implied warranty of applicability for other thanresearch uses by qualified individuals. DELSYS INC. shall notbe liable to any person for any medical expenses or any direct orconsequential damages resulting from any defect, failure or mal-function, whether a claim for such damages is based upon theoryof 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 ofanything about this product.Limited WarrantyThe TrignoTM Wireless EMG Systems are warranted against fail-ure of materials and workmanship for a period of 1 year from thedate of delivery, provided that the product is given proper careand has not been subject to abuse during this period. This war-ranty is in lieu of all other warranties expressed or implied.Operation of this device outside specifications determined byDELSYS INC. or use with any other input devices other thanDELSYS INC. sensors constitute an invalidation of this limitedwarranty. This warranty is not transferable.
8 Trigno Wireless EMG System User’s GuideTMTrignoTM Wireless EMG SystemThe TrignoTM Wireless EMG System is a high-performingdevice unparalleled in its sophistication, its reliability and itsease-of-use. Each EMG sensor has a built-in triaxialaccelerometer, a guaranteed transmission range of 20m and arechargeable battery lasting 7 hours. The system is capable ofstreaming data to EMGworks Acquisition and Analysis softwareand of generating 16 EMG and 48 accelerometer analogchannels for integration with motion capture and other 3rd partydata acquisition systems. Full triggering features further expandthe possibility for integration with additional measurementtechnologies.Figure 1. Complete Trigno Wireless System1Wireless Sensor 5Analog Output Connectors2Base Station 6Trigger Port3USB Port 7Antenna4Power Jack/Power Supply 8EMGworks Software (not shown)1264753
9TrignoTM System ComponentsWireless EMG SensorEach Trigno Sensor is equipped with the following features:•transmission range of 20m•inter-sensor latency < 500us•self-contained rechargeable battery•EMG signal bandwidth 20- 450 Hz •EMG signal sampling rate of 4000 samples/sec•EMG baseline noise of 3uV pk-pk•CMRR > 80dB•16-bit EMG signal resolution•integrated triaxial accelerometer •software selectable accelerometer sensitivity of ± 1.5g or ±6g•LED User feedback •battery charge monitoring and status indicator•environmentally sealed device •proven parallel bar technology•contoured sensor-skin interface for maximum signal stability•auto shutoffSensor LED Indicator StatusStatus LED BehaviorData Streaming flashing green, 1 second cycleScanning alternating green/amber flash, 1 second cyclePairing Solid Amber, button depressedPairing Successful Rapid green flashing, button depressedPairing Unsuccessful Rapid red flashing, 5x, button depressedMode Switch Rapid green flashing, 3xFirmware Update Rapid green flashing, 3xBattery Charging Solid amber, in cradleCharging Complete Solid green, in cradleCharging Error LED off, sensor in cradle, cradle powered upSensor Off LED offXYZ
10 Trigno Wireless EMG System User’s GuideTMBase StationEach Base Station is equipped with the following features:•recharging cradle for 16 sensors•high speed USB communication with PC•64-channel analog output connector (16 EMG, 48 ACC)•± 5V analog output range•detachable Antenna•full trigger capability (Start/Stop, Input/Output)•communication feedback LED•power LEDFigure 2. Trigno Base Station Power SupplyTrigno Systems are equipped with an isolated medical gradepower supply. The green power LED on the base station willilluminate when power is connected to the Base Station. Thepower supply is provided with interchangeable country-specificplug adapters. Please contact Delsys if specialized adapters arerequired. The power supply can be conveniently stored in theBase Station storage space when the system is not in use. Figure 3. Trigno Power Supply
11Trigno System are specifically designed and approved tofunction only with the provided Power Supply. Power Supplysubstitutions constitute a violation of the medical safetyapprovals and will void the warranty.If using a mains-powered PC then an additional isolationtransformer is required for medical compliance to IEC60601-1.Refer to Appendix I for further details. No PC isolation isrequired for operation on a battery-powered laptop.Sensor Adhesive Skin InterfacesTrigno sensors can be affixed to the body with convenient dou-ble-sided adhesive interfaces. Ensure that the sensor site iscleaned with isopropyl alcohol immediately prior to application.It is recommender to affixed the interface first to the sensor, tak-ing care to properly align the sensor contacts with the slots, andthen to the skin site.Figure 4. EMG Sensor Adhesive Skin Interfaces Adhesive Sensor Interfaces are for single use only. Immediately discontinue use if skin irritation or discomfort occurs. All Adhesive Sensor Interfaces and Reference Electrodes are for single use only. Discard after using. Reseal storage bag to maintain freshness.
12 Trigno Wireless EMG System User’s GuideTMGetting Started with the TrignoTM System Powering the Base StationConnect the Trigno power supply to the circular DC jack locatedon the side of the Base Station. Energize the power supply byconnecting it to a Mains outlet or to an isolation transformer.Ensure that the PC to be used with the Base Station is connectedto the same isolation transformer. Please refer to Appendix I forclarification on using an Isolation Transformer. The power LEDon the Base Station will illuminate anytime power is applied.Ensure that the Base Station antenna is securely attached to theantenna connector.Charging the SensorsBefore using the system, the sensors should be fully charged byplacing them in the Base Station cradle slots. Ensure the BaseStation is powered and that the green power LED is illuminated.When charging, the sensor LEDs will illuminate to an ambercolor. Once the sensor battery is fully charged the sensor LEDwill turn off. A blinking LED indicates an incomplete charge.Remove the sensor from the device and let stand for 5 minutes.Cycle power on the Base Station and re-dock the sensor torestart the charge cycle. A complete charge cycle form a fullydepleted sensor takes approximately 2.5 hours.Recharge only with the approved power supply originallyincluded with the system. Charging with any other powersupply may damage the device and will void the warranty.Turing the Sensor ONTrigno Sensors are turned on by depressing the rubber button forapproximately one second. The green LED on the sensor willimmediately begin to flash, and begin searching for a BaseStation within its range. If no Base Station is found, the LEDwill alternate between amber and green, indicating that it doesnot have an established communication link. As soon a link isestablished with the Base Station, the sensor LED will flashgreen approximately once per second, indicating that data isstreaming.
13Using EMGworks with the TrignoTM SystemInstall EMGworks according to the instructions provided withthe software. Define a Hardware Configuration and an appropri-ate Test as described in the EMGworks User’s Guide. Note thatthe sampling rate for Trigno Sensors is fixed 4000 samples/secfor EMG data and 296 samples/sec for accelerometer data. When the Trigno Test is initiated, the Trigno System Consolewill appear in a separate window. This console monitors thestatus of the Base Station and Sensors in real time to give theUser appropriate feedback on battery voltage, number ofdropped frames and makes available sensor settings such asaccelerometer range and transmission channel selection.Note that the sensor must be turned on and linked to the Baseprior to initiating data acquisition in EMGworks.
14 Trigno Wireless EMG System User’s GuideTMUsing the Wireless EMG SensorsOrienting the EMG Sensors on the SkinThe Trigno EMG Sensor is fitted with 4 silver bar contacts fordetecting the EMG signal at the skin surface. It is crucial that theorientation of these bars be perpendicular to the muscle fibersfor maximum signal detection. The top of the sensor is shapedwith an arrow to aid in the determination of this orientation. Thearrow should be placed parallel to the muscle fibers underneaththe sensor. The sensor should also be placed in the center of themuscle belly away from tendons and the edge of the muscle. Thesensor is easily attached to the skin using the Delsys AdhesiveSensor Interface.Figure 5. EMG Sensor orientation with respect to the muscle fibers. It is important that the orientation of the arrow on the sensor be parallel to the underlying muscle fibers.Muscle Fiber Direction
15Using the Delsys Adhesive Sensor InterfaceThe Adhesive Sensor Interfaces use medical-grade adhesive spe-cifically designed for dermatological applications. Usage of theinterface promotes a high quality electrical connection betweenthe sensor bars and the skin, minimizing motion artifacts and theill-effects of line interference. To ensure a strong bond with theskin, it is advised to remove excessive hair and wipe the skinarea and the EMG Sensor with isopropyl alcohol to remove oilsand surface residues. Allow the skin to dry completely beforeapplying the interfaces.Figure 6. Application of the Adhesive Sensor Interface. Adhesive Sensor Interfaces are for single use only. Immediately discontinue use if skin irritation or discomfortoccurs. All Adhesive Sensor Interfaces and ReferenceElectrodes are for single use only. Discard after using.Reseal storage bag to maintain freshness.1) Remove the interface from its strip and apply to the sensor.2) Remove liner to expose the adhesive.3) Apply to the skin site. Do not reposition once skin contact is made.
16 Trigno Wireless EMG System User’s GuideTMMaintenance and CareTrigno SensorsTrigno sensor are encased in a sealed polycarbonate enclosure.The following points should be kept in mind when handling thesensors.•All sensors should be visually inspected before each use toensure that no mechanical deterioration has occurred.•The sensors can be cleaned and sterilized with a damp clothand mild detergent, with isopropyl alcohol swabs, or with a70% isopropyl alcohol solution. Ensure that the sensor con-tacts remain clean at all times for proper operation.•The sensors are completely sealed and are water-resistant.These can be used on damp skin surfaces and in the presenceof sweat without compromise to safety, sensor integrity oroperation. The sensors should never be completely sub-merged in any liquid.•The sensor contacts are made of pure silver and are quitesoft. Care should be taken to preserve the integrity of thesecontacts. Do not scrape or dent these contacts. •Handle the sensors with care: do not drop them on the groundor step on them.Do not submerge the sensors in any liquid under anycircumstance.The sensors contain sensitive electronic circuitry. Staticdischarges and intense magnetic fields should be avoided toprevent possible irreparable damage to the sensors.Recharging Base Station The Trigno System is designed to provide years of reliable ser-vice when proper care is followed. While the Base Station enclo-sure is made of durable plastic, the following points should bekept in mind when using and handling it:•The device and its accessories should be visually inspectedbefore every use to ensure that no mechanical deteriorationhas occurred.
17•The Base Station can be easily cleaned with a damp cloth andmild detergent or with a 70% solution of isopropyl alcohol.DO NOT IMMERSE THE BASE IN LIQUID.•The units are not shockproof and should not be dropped or besubjected to excessive forces or accelerations.The recharging Base Station is not water-resistant. Under nocircumstance should this unit be exposed to water or anyother type of liquids.
18 Trigno Wireless EMG System User’s GuideTMSpecificationsTrigno SensorsGENERAL SPECIFICATIONSTypical Operating Range 10 mTransmission Source 2.4 GHz, 1 mWPower Consumption <66 mWCase Dimension 41 x 20 x 5 mmCase Material polycarbonateOperation Time/charge >8 hoursRecharge Time <2.5 hoursMass < 10gAuto Shut-down timer 5 minutesTemperature Range(1) 5 - 50 degrees CelsiusEMG SENSOR SPECIFICATIONSResolution (EMG Signal) 168 nV/bit, 16 bitsRange 11 mV (r.t.i.)Bandwidth (EMG Signal) 20±5 Hz, >40 db/dec450±50 Hz, >80 dB/decPassband Ripple <2%Overall Channel Noise <0.75uV (RMS, RTI)CMRR >80 dBSampling Rate(2) 2000/4000 samples/secNumber of Contacts 4Contact Dimension 5 x 1 mm.Contact Material 99.9% Ag
19Trigno Recharging Base Station(1) Operation beyond these limits may damage the rechargeable battery.(2) Software selectable(3) Delay from sensor event to analog output is fixed.ACCELEROMETER SPECIFICATIONSNumber of Axis 3Range(2) ±1.5g±6g Resolution(2) 0.012g/bit, 8 bits 0.047g/bit, 8 bitsBandwidth DC - 50±5 Hz, >20dB/decSampling Rate(2) 148 / 296 samples secGENERAL SPECIFICATIONSTypical Operating Range 10 mTransmission Source 2.4 GHz, 1 mWPower Consumption <10WSensor Recharge Time < 2.5 hoursUSB type USB 2.0 compliant, high speedTemperature Range(1) 5 - 50 degrees CelsiusMaximum number of Sensors 16Inter-sensor delay <500 usANALOG OUTPUT SPECIFICATIONSNumber of outputs 16 EMG, 48 AccelerometerSignal group delay(3) <50 msEMG Signal Range ±5 VAccelerometer Signal Range ±1.5 VConnector Type SCSI-68, Type II
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