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Device Information

Complies with Requirements put forth by the Medical Device Direc-
tive 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-W05 (Trigno Sensor)
FCC ID: W4P-SP-W01 (Trigno Sensor)
IC: 8138A-DST01 (Model: Trigno Wireless EMG System)
IC: 8138A-SPW05 (Model: SP-W05)

This device complies with Part 15 of the FCC Rules and Industry Can-
ada’s RSS-210 License Exempt Standards. Operation is subject to the
following two conditions: (1) This device may not cause harmful inter-
ference. 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.

REP

EC

EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands

DELSYS INC.
650 Beacon St.
Boston MA 02215
USA

Authorized Representative

Manufacturer

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Содержание Tringo

Страница 1: ...012 Edition PM W01 Copyright 2012 by Delsys Incorporated Specifications 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 2 4 TM ...

Страница 2: ......

Страница 3: ...ng the Sensors 14 Acquiring Data in EMGworks Acquisition 15 Sampling the Analog Outputs 15 Digital Outputs Trigno SDK 15 Using the Wireless EMG Sensors 16 Orienting the EMG Sensors on the Skin 16 Cleaning the Sensor Site 16 Applying the Trigno Adhesive Skin Interfaces 16 Turning the Sensors ON 17 Trigno Sensor Status Console 17 Turning the Sensors Off 18 Using the Analog Outputs 19 Analog Output C...

Страница 4: ...EMGworks 30 Using Tandem Trigno Systems 31 Initial Connectivity 31 Communication Frequencies 31 Synchronization 31 User Interface 32 Maintenance and Care 33 Trigno Sensors 33 Trigno Base Station 33 Specifications 35 Trigno Sensors 35 Trigno Recharging Base Station 37 Appendix I 39 Mains Isolation 39 Appendix II 40 DC A22 Unterminated Output Cable 40 Installation 40 DC A22 Conductor Assignments 41 ...

Страница 5: ...he EMG signal by a qualified professional is required Rx ONLY Contraindications Technical Service and Support For information and assistance visit our web site at www delsys com Contact us at E mail support delsys com Telephone 617 236 0599 DO NOT USE on Patients with implanted electronic devices of any kind including cardiac pace makers or similar assistive devices elec tronic infusion pumps and ...

Страница 6: ...iately 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 compli...

Страница 7: ...Sensor FCC ID W4P SP W01 Trigno Sensor IC 8138A DST01 Model Trigno Wireless EMG System IC 8138A SPW05 Model SP W05 This device complies with Part 15 of the FCC Rules and Industry Can ada s RSS 210 License Exempt Standards Operation is subject to the following two conditions 1 This device may not cause harmful inter ference and 2 this device must accept any interference received including interfere...

Страница 8: ...rotection against harmful interference in a residential installation This equipment gen erates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful inter ference to radio communications There is no guarantee that interfer ence will not occur in a particular installation If this equipment does cause harmful interference to r...

Страница 9: ... tract tort or otherwise No representative agent or licensed practi tioner is authorized to waive this disclaimer DELSYS INC makes no diagnosis or prescription by virtue of anything about this prod uct System Requirements EMGworks 4 0 9 or later Windows 7 Windows Vista or Windows XP with service pack 3 64 bit or 32 bit operating systems supported Windows 7 is recommended for optimal performance On...

Страница 10: ...tures further expand the possibility for integration with additional measurement technologies Wireless EMG Sensor Each Trigno Sensor is equipped with the following features transmission range of 40m inter sensor latency 500us 1 sample period self contained rechargeable battery EMG signal bandwidth 20 450 Hz EMG signal sampling rate up to 4000 samples sec EMG baseline noise of 750 nV RMS CMRR 80dB ...

Страница 11: ...atus LED Behavior LED Data Streaming Flashing green 1 Hz Scanning Alternating green amber flash 1Hz Pairing Successful Rapid green flashing 3x button depressed Pairing Unsuccessful Rapid red flashing 3x button depressed Mode Switch Rapid green flashing 3x Firmware Update Rapid green flashing 3x Battery Charging Solid amber in cradle Charging Complete Solid green in cradle Charging Error LED off se...

Страница 12: ...ation storage space when the system is not in use Figure 3 Trigno SC P05 International Medical Power Supply with plug adapter kit Trigno System are specifically designed and approved to function only with the Power Supply provided Power Supply substitutions constitute a violation of the medical safety approvals and will void the warranty If using a mains powered PC then an additional isolation tra...

Страница 13: ...r supply by con necting it to a Mains outlet or to an isolation transformer Ensure that the PC to be used with the Base Station is connected to the same isolation transformer Please refer to Appendix I for clarifica tion on using an Isolation Transformer The power LED on the Base Station will illuminate anytime power is applied Ensure that the Base Station antenna is securely attached to the anten...

Страница 14: ...tery is fully charged the sensor LED will turn green A complete charge cycle from a fully depleted sensor takes approximately 2 5 hours Do not force the sensors into the recharging cradles of the Base Station The sensors are keyed so that they can only be inserted in one orientation Check the sensor orientation and check for obstructions in the cradle if physical resistance is met while cradling t...

Страница 15: ... collection in EMGworks Whenever data are collected in EMGworks the analog outputs on the base station are also active so it is possible to collect data in EMGworks and in a secondary data acquisition system simultaneously Sampling the Analog Outputs If samplig the analog output signals from the Trigno System using a 3rd party data acquisition system refer to the Using the Analog Outputs section o...

Страница 16: ...direction of the underlying muscle fibers Cleaning the Sensor Site Prior to affixing 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 d...

Страница 17: ...r button for approximately one second The green LED on the sensor will immediately begin to flash and begin searching for a Base Station that has been properly paired and is within its range If no Base Station is found the LED will alternate between amber and green indicating that it does not have an established communication link As soon a link is established with the Base Station the sensor LED ...

Страница 18: ...igure 8 The Trigno Sensor Status Console offers real time sensor feedback A data acquisition status B battery charge state C sensor number D sensor power E wireless signal strength F sensor pairing G off command Turning the Sensors Off There are several mechanisms for turning the Trigno sensors off described as follows Send an off command via software Dock the sensor in an active charge cradle Hol...

Страница 19: ...nals exhibit fixed 48 and 96ms delays respectively from the time the sensor detects the event to the time the analog signal is reproduced Figure 9 Analog output connectors Analog Output Connectors Channels 1 16 EMG Signals The pinout of this connector replicates the pinout of the Bagnoli desktop EMG systems to facilitate connectivity between shared equipment Only EMG signals are provided on this c...

Страница 20: ... In these cases Delsys can supply a cable assembly that mates with the analog output connectors and breaks out the individual channels onto single conductors Please contact Delsys for details regarding this particular wire assembly or other connectivity needs Please refer to Appendix II for further details regarding the DC A22 Unterminated Output Cable Figure 11 DC A22 Unterminated Output Cable ...

Страница 21: ...e Delsys web site at http www delsys com Products EMGworks html There is no license required to use the Trigno Control Utility The system requirements for the Trigno Control Utility software is the same as EMGworks detailed in the EMGworks User s Guide http www delsys com KnowledgeCenter NetHelp Launching the Software When installed the Trigno Control Utility software may be launched from the Star...

Страница 22: ...22 Trigno Wireless System User s Guide TM Figure 12 Trigno Control Utility software Figure 13 Trigno Control Utility software with active outputs ...

Страница 23: ...rdware node of the Configuration Tree when the Trigno Wireless System is selected as the primary A D device Figure 14 Selecting the Trigno system as the primary A D device in the Hardware node of the Configuration Tree in EMGworks When using the Trigno Control Utility these options can be set by clicking the Configure button Figure 15 Configure button in Trigno Control Utility ...

Страница 24: ...rum Four frequency sets are available A B C and D The current frequency set is shown here Firmware Version Delsys may occasionally release firmware upgrades to improve and evolve the functionality of Trigno Systems The current firmware version is shown here Serial Number Each Trigno Base Station has a unique serial number and identifier address which is shown here Network Size Indicates the number...

Страница 25: ...d Figure 17 Configuring Trigno Sensor Settings Frequency Set Use this setting to change the frequencies being used for wireless communication The default set is A The frequency set should only be changed if nearby sources are interfering with Trigno communications or the particular operating environment is causing significant path loss on the current frequency set Note that changing the communicat...

Страница 26: ...tion the sensor mode is controlled on the Mode Control tab of the Configuration dialog Information on mode control is available through our EMGworks online help http www delsys com Products EMGworks html Test Panel The Test Panel is used to verify the analog signal connections with the data acquisition module by outputting predefined and unique signals on each channel The test signals are sinusoid...

Страница 27: ...27 expected outputs for each analog channels are listed in the Test Panel window once the option is slected Figure 18 The Test Panel Signals ...

Страница 28: ...ded if sensors are being replaced within the network group when the communication frequency sets are changed and after a firmware upgrade is performed 1 Initiate sensor pairing in software When using EMGworks initiate pairing by right clicking the Trigno hardware icon in the system notification area and selecting the appropriate menu item Figure 19 Location of the Trigno hardware icon in the syste...

Страница 29: ...ally 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 software will prompt the user to enter factory calibration data which can be obtained from Delsys Factory calibration data are a string of numbers and letters which encode the calibration values for a specific se...

Страница 30: ...ll verify that the sensors currently communicating match those used in the configuration If there is a mismatch cancel the recording and re pair the sensors Figure 23 Refresh Smart Sensors button Sensor Modes in EMGworks Each 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 s...

Страница 31: ... cable will work irrespective of orientation Figure 25 Installation of the Trigger Cross Over cable to synchronize two base stations when used with EMGworks Communication Frequencies When the software detects the presence of two bases connected to the computer the frequency sets on each base are automatically changed to allow the simultaneous communication of 32 sensors The user is required to re ...

Страница 32: ...32 Trigno Wireless System User s Guide TM User Interface User interface options are expanded to reflect the presence of additional sensors Figure 26 The Status Console when tandem bases are used ...

Страница 33: ... are quite soft 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 ground or step on them Do not submerge the sensors in any liquid under any circumstance The sensors contain sensitive electronic circuitry Static discharges and intense magnetic fields should be avoided to prevent the risk of irr...

Страница 34: ...he units are not shockproof and should not be dropped or be subjected to excessive forces or accelerations The recharging Base Station is not water resistant Under no circumstance should this unit be exposed to water or any other type of liquids ...

Страница 35: ... of original battery capacity is maintained after 300 discharge recharge cycles or after 2 years if recharge cycles are less than 300 These values represent typical expectations under normal conditions Actual performance will vary depending on usage conditions 4 Operation beyond these temperature limits may damage the rechargeable battery GENERAL SPECIFICATIONS Typical Operating Range 1 40 m RF Fr...

Страница 36: ...lerometer range is software selectable 2 Resolution is calculated with 8 bits over the full 3 3V dynamic range encompassing accelerometer ideal maximum outputs of 2 1g and 8 0g Ratings exceeding the nominal range of 1 5g and 6 g may be non linear and are not guaranteed 3 Calculated over a 50 Hz bandwidth and range setting of 1 5g 4 Offset errors can nulled in software by using a calibration routin...

Страница 37: ...is parameter relates the detected voltage input at the sensor to the reproduced voltage at the EMG channel output 3 Sin X X correction is applied to each channel for cancelling the distorting effects of the DAC sampling process GENERAL SPECIFICATIONS Typical Operating Range 1 40 m RF Frequency Band 2400 2480 MHz ISM Power Consumption 6 W operation 14W during recharge Sensor Recharge Time 2 5 hours...

Страница 38: ...ibrated voltage differential for an inertial displacement of 1 g 3 Sin X X correction is applied to each channel for cancelling the distorting effects of the DAC sampling process ACCELEROMTER ANALOG OUTPUT SPECIFICATIONS Number of outputs 16 X Axis 16 Y Axis 16 Z Axis Signal group delay 1 96 ms Accelerometer Output Signal Range 5 V Nominal Accelerometer Signal Gain 2 2 424 V g 5 1 5g range 0 624 V...

Страница 39: ...to have all patients electrically isolated from equipment within their reach and since the PC running the Trigno Software is conceivably within their reach it too must be isolated Delsys does not supply isolation transformers for Personal Computers and their peripherals Delsys recommends model IS1000HG manufactured by Tripp Lite www tripplite com for this task This device is a medial grade isolati...

Страница 40: ...olor and it is marked with a secondary color An example of the coloring scheme is shown in Figure 27 below Figure 27 Wire color scheme example Installation Refer to Figure 28 for installing the DC A22 cable Please observe the following points Connect the GND wires to the data acquisition system ground for analog inputs It is recommended to twist all three wires together and connect these to a comm...

Страница 41: ...G 4 62 Blue Pink AY 12 10 Tan Brown AX 4 61 Green Pink AZ 12 11 Tan Pink AY 4 27 Pink Green EMG 13 42 Violet White AZ 4 28 Pink Blue AX 13 41 Blue White EMG 5 60 Yellow Pink AY 13 7 White Blue AX 5 59 Orange Pink AZ 13 8 White Violet AY 5 25 Pink Orange EMG 14 40 Green White AZ 5 26 Pink Yellow AX 14 39 Yellow White EMG 6 58 Gray Brown AY 14 5 White Yellow AX 6 57 Violet Brown AZ 14 6 White Green ...

Страница 42: ...42 Trigno Wireless System User s Guide TM ...

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