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Noraxon ultium EMG Hardware User Manual

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Ultium EMG Hardware User Manual
Hardware User Manual
1
(Rev Q)

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Summary of Contents for Noraxon ultium EMG

  • Page 1 Ultium EMG Hardware User Manual Hardware User Manual (Rev Q)
  • Page 2 Check for Normal Signal Display with Interface to a PC ..............22 Check Signal Quality ..........................23 Record Signal as Desired ........................25 Shutdown after Use ..........................25 6.10 Storage and Protecting Between Use ....................25 Additional Ultium EMG Settings and Features .................... 26 Ultium Receiver Synchronization ......................26 (Rev Q)
  • Page 3 Ultium EMG Hardware User Manual 32-Channel Operation ..........................27 Digital Filters ............................27 Lossless Data Recovery ........................28 Ultium Internal Inertial Measurement Unit (IMU) ................29 Signal Processing for Amplitude Normalization ................31 Maintenance ..............................31 Consumable Items ..........................31 Maintenance by Users ...........................
  • Page 4 Noraxon and myoRESEARCH are registered trademarks and the Noraxon logo, myoANALOG, myoFORCE, myoMETRICS, myoMOTION, myoMUSCLE, myoPRESSURE, myoVIDEO, myoSYNC, NiNOX, TRUsync and Ultium are common-law trademarks of Noraxon U.S.A., Inc. All other trademarks are the property of their respective owners. ©2018, all rights reserved.
  • Page 5 1.1 Risks and Benefits There is no identified risk of physical harm or injury with use of the Ultium EMG System. The benefit provided by use of the device is the provision of objective measures to assess the severity of pathological human movement conditions and gauge any subsequent improvement offered by therapy, training or design changes.
  • Page 6 Ultium EMG Hardware User Manual Guidance on Conditions for Safe Use • The Ultium EMG sensors are suitable for use as medical devices. To ensure safe operation the following guidelines must be strictly followed. • The Ultium Receiver, Ultium Sensor Charger, and computer must not be accessible (touchable) by the patient.
  • Page 7 2.3 Intended Use Noraxon’s Ultium EMG sensor is intended to measure and quantify muscle biopotential signals separately or in combination with other kinematic or kinetic signals. These inter-related measurements can provide data to assist in understanding movement abnormalities. The system is designed as a measuring tool for clinical, investigational and research applications.
  • Page 8 Special Concerns The Ultium EMG system operates by means of microwave radio frequency transmissions. Certain (older, vintage model) pacemaker devices may be susceptible to such microwave transmissions. Therefore, use of the device is contra-indicated in individuals who have implanted pacemakers.
  • Page 9 Ultium EMG Hardware User Manual 3 Definitions 3.1 Graphic Symbols and Meaning The following international icons and symbols are found on the Ultium enclosures and in this user manual. Their meaning is described below. Approval to market this product (#870/876) in the European Community was certified by Notified Body #2797 BSI.
  • Page 10 Ultium Receiver – A USB-connected Receiver which receives signals from one or more EMG sensors. Ultium EMG Sensor -- A small individual radio transmitter typically worn on the body used to measure and transmit bio-potential signals (such as EMG) or motion related signals (such as position or acceleration).
  • Page 11 ● 4.2 Product Versions and Configurations The model 880 Ultium Receiver can accommodate up to 16 Ultium EMG Sensors. The standard model 810 Sensor contains a 3-axis inertial measurement unit and can be combined with any of the following SmartLead types:...
  • Page 12 Upon arrival, carefully remove all contents and verify the following components are present. Figure 2 – Ultium Sensor Charger (#873) Figure 1 – Ultium Receiver (#880) Figure 4 – Ultium EMG Smart Lead (#842) Figure 3 – EMG Sensor (#810) Figure 7 –...
  • Page 13 Ultium EMG Hardware User Manual 5.2 Ultium Receiver Overview Receiver (Front) 1. Status LED – Indicates the status of the Receiver. 2. Charging Dock Port – Connects the Sensor Charger to the Receiver for communication. Receiver (Back) 1. Sensor Power Button – Push to toggle power on sensors inserted into connected chargers.
  • Page 14 Ultium EMG Hardware User Manual 5.3 Ultium EMG Sensor Overview EMG Sensor (Front & Top) 1. Status LED – Sensor operational indicator flashes green when measuring. Solid Yellow when charging. 2. Power Button – Power the sensor On/Off. Hold for 3+ seconds for a hard reset.
  • Page 15 Ultium EMG Hardware User Manual 5.4 Hardware Setup Instructions Step 1 Insert the USB-B (smaller) end of the USB cable (#CBL2) into the USB connector on the rear of the Ultium Receiver (#880). Insert the opposite end of the USB cable into an available USB port on the computer.
  • Page 16 Noraxon’s myoRESEARCH ® needs to be installed on the computer. Note: The Ultium Receiver requires the Noraxon USB device driver which is pre-installed by the MR software installation. It is also available in the Downloads Section of the Noraxon website.
  • Page 17 Ultium EMG Hardware User Manual 5.6 Configuring the Hardware Before the Ultium system can be used, the device software settings must be configured to recognize the different components that make up the system. Follow the below instructions to update the receiver firmware, sensor firmware, and populate sensors to prepare for a data collection.
  • Page 18 Ultium EMG Hardware User Manual Step 4 Make sure the EMG or SmartLead Sensors are placed in the Charger(s) and the Charger(s) are connected to the Ultium Receiver, then click Detect Sensors in Chargers to load all sensor serial numbers into the MR software.
  • Page 19 EMG sensors (the medical device) which wirelessly transmit the measured signals to any receiver that is part of the Ultium EMG Family. In the case of the Ultium Receiver, the receiver is attached to a general-purpose computer via a USB connection which may include an optional (non-medical) USB Hub.
  • Page 20 (Some skin preparation for the reference pad site may be beneficial if the EMG signal exhibits a wandering baseline. See Appendix A) The EMG Sensors can be secured in place using Noraxon supplied double-sided adhesive tape and/or elastic straps. Straps are recommended if dynamic movements are expected.
  • Page 21 Ultium EMG Hardware User Manual Step 2 Insert the Ultium EMG device into the configuration by dragging it from the Available Devices list to the Devices in Your Configuration area. Step 3 Select the channels to include in the measurement by clicking the checkmark.
  • Page 22 Ultium EMG Hardware User Manual Step 5 Click STOP to end the recording, then enter a name for the new record. Click Save & View to view and begin processing the record. Click Discard & Measure Again or Save & Measure Again to return to the measurement screen.
  • Page 23 6.7 Check Signal Quality Electromyography recordings are depending on many best practice standards to ensure ideal signal quality. Within the Noraxon myoRESEARCH platform, standard procedures and best practice functionality has been built to assist the practitioner with identifying their current signal quality. With the Ultium system, a live signal status monitor provides real-time information for practitioners to understand the current recording conditions.
  • Page 24 Ultium EMG Hardware User Manual Related Software Measurement Tools Within the Noraxon myoRESEARCH software is a suite of tools that can be used during EMG measurements. Below is a list of the most used features for electromyographic recordings. Additional information around more advanced features can be found on www.noraxon.com...
  • Page 25 Ultium EMG Hardware User Manual 6.8 Record Signal as Desired After checking the status monitor and impedance of your signals, you are ready to record a measurement. Select Record at the top left of the screen and begin your protocol. After completing your record, select Stop.
  • Page 26 To enable Sync, simply check the Use Noraxon MyoSync checkbox. When Use Noraxon MyoSYNC is enabled in Hardware Setup, the digital channel will be labeled Sync. If MyoSYNC is not enabled, the channel will be labeled Switch and can be used as a generic digital input.
  • Page 27 FIR filters that do not follow a named filter convention. Due to the architecture of the A/D in the Ultium EMG sensor, the output has a sinc filter applied. This creates a passband within the desired passband range. To make the passband flat, we apply an inverse...
  • Page 28 Ultium EMG Hardware User Manual sinc filter which is the mirror of the original sinc filter applied with a low pass cutoff. The net effect is that the measured EMG has a very flat passband and steep low pass cutoff due to the 128 order filter.
  • Page 29 Ultium EMG Hardware User Manual 6. Selection of ‘Offline data recovery’ will then provide you with a list of all records that have lost data. 7. Select each record that you would like to recover at this time. 8. Place all the sensors (#810) in the sensor charger (#873), connect the charger to the receiver (#880), and then plug the receiver into the PC as demonstrated in steps 1,3, and 5 of section 5.4 of this manual.
  • Page 30 Ultium EMG Hardware User Manual Acceleration channels will then be available under the sensor name. Note: The order of analog outputs changes when the Internal Accelerometer is enabled. Instead of using outputs 1 and 2 for EMG 1 and EMG 2, acceleration channels use outputs 2-4 and 6-8. This can be changed, and any channel can be unused by simply unchecking the box next to it.
  • Page 31 Sensor periodically (see below for information on how to clean the bottom pads). Because the EMG sensor batteries are Li-Ion, the only battery maintenance required is recharging. Charging the EMG Sensors Safety precautions for charging the EMG Sensors: No Precautions required. The Ultium EMG Sensors are charged using the Ultium Sensor Charger. Step 1 Verify that all the sensors are correctly inserted into the Ultium Sensor Charger (#873).
  • Page 32 The EMG Sensors are not warranted against exposure to any of the conventional forms of sterilization (autoclave, heating, etc.). Users wishing to utilize this equipment in a sterile environment, such as an operating theater, should consult Noraxon for other options. Only use a damp cloth with mild soap and water or isopropyl alcohol to clean ●...
  • Page 33 The EMG sensor battery packs may not be replaced by the user. Only qualified Noraxon technical personnel may perform maintenance. Your Ultium EMG purchase comes with free battery replacement for the lifetime of the sensor*. To initiate a Battery Replacement Form, visit the Support section at Noraxon.com.
  • Page 34 (esp. at long distances) of-sight relationship between sensor and Receiver 9.2 Website Link to FAQ Answers to frequent questions can be found at Noraxon’s Frequently Asked Questions (FAQ) website page at this link: https://www.noraxon.com/support-learn/technical-support/faqs/ Other educational material is available at this link: https://www.noraxon.com/support-learn/technical-support/...
  • Page 35 Ultium EMG Hardware User Manual 9.3 Radio Considerations The Ultium radio system operates in the 2400 MHz ISM (Industrial, Scientific and Medical) radio band reserved for use in most countries of the world. The radio transfers data digitally using a proprietary wireless sensor protocol.
  • Page 36 If you are shipping from outside the USA please use UPS, FedEx, DHL, or EMS (US Postal Service) and not a freight-forwarder. Using a freight-forwarder incurs additional brokerage fees. If a package is shipped to Noraxon via a carrier other than the ones listed above, it may be refused. 11 Taking Product out of Operation 11.1 Disposal of Equipment and Batteries...
  • Page 37 Model 810 Ultium EMG Sensor Each Ultium EMG transmitter module (#810) incorporates one transceiver module together with an analog front end and supporting circuitry. The #810 EMG Sensor is powered by one 150mAh battery; each is identified by a unique serial number.
  • Page 38 Ultium EMG Hardware User Manual 12.2 Electro-Magnetic Compatibility Tables Guidance and manufacturer’s declaration – electromagnetic emissions The Ultium System is intended for use in electromagnetic environment specified below. The customer or the user of the Ultium System should assure that it is used in such an environment.
  • Page 39 Ultium EMG Hardware User Manual Guidance and manufacturer’s declaration – electromagnetic immunity The Ultium System is intended for use in electromagnetic environment specified below. The customer or the user of the Ultium System should assure that it is used in such an environment.
  • Page 40 Ultium EMG Hardware User Manual Recommended separation distances between portable and mobile RF communications equipment and the Ultium System The Ultium System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ultium System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ultium System as recommended below, according to the maximum output power of the communications equipment.
  • Page 41 Ultium EMG Hardware User Manual 13 Appendices 13.1 Appendix A – Product Specifications Expected Useful Lifetime Both the Ultium Receiver (#880) and EMG Sensors (#810) have a usable life of seven years. The EMG sensors operate with a rechargeable Lithium-Ion battery. The battery capacity will decline with ongoing use and require replacement after 300+ discharge/charge cycles to preserve the device’s...
  • Page 42 Ultium EMG Hardware User Manual Performance Characteristics Output & Transmission Frequency (Depending on country) Up to 100 mW (depending on country allowance) ● ● GFSK 2402-2480 MHz, frequency hopping Utilizing up to 79 hopping channels ● Channel-to-channel hopping frequency 50Hz (20 msec) ●...
  • Page 43 Surface EMG applications. Other electrodes may be used, but it is recommended that any electrodes used with the Ultium EMG sensors satisfy the requirements for standard ANSI/AAMI EC12-1991 Disposable ECG electrodes.
  • Page 44 (next to the person’s head). At present, Noraxon identifies no restrictions on use and placement of the EMG sensors on any portion of the human body. The EMG sensors operate at radio frequencies known to effect older style pacemakers.
  • Page 45 Ultium EMG Hardware User Manual 13.4 Appendix D – Radio Regulatory Statements FCC 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.
  • Page 46 Ultium EMG Hardware User Manual 13.5 Appendix E – Ultium SmartLead Specifications Model 802 Footswitch Input Channels: 4 (4-zone FSR) Sample Rate: 2000/4000Hz FSR Response Time: ~2ms Output Signal Range: 0 to +5V Digital/Analog output voltages: Heel: 0.266V M5: 0.533V M1;...
  • Page 47 Ultium EMG Hardware User Manual Model 820 500-lbf Force Sensor Input Channels: 1 Sample Rate: 2000/4000Hz Input Range: +/- 500 lbf (+/- 2224 N) Resolution: 0.016 lbf Analog Output scale factor: 9.524 mV/lbf Model 821100-lbf Force Sensor Input Channels: 1...
  • Page 48 Ultium EMG Hardware User Manual 13.6 Appendix F – Ultium Analog Output Module (Model 881) The Ultium Analog Output Box can be used to transmit data collected from the Ultium System to a 3 party software/program in real-time. This device can be used to connect the Ultium receiver (via one of...
  • Page 49 Wait 60 seconds for the light to change to dark blue. If the light does not change to flashing dark blue after 3 repeated tries, please contact Noraxon Support (support@noraxon.com). Solid or flashing red...
  • Page 50 Ultium EMG Hardware User Manual (Rev Q)