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1 | User Manual | Users Manual | 441.10 KiB |
EXTERNAL NEUROSTIMULATOR 4NR003 User manual Rx only CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. c CAUTION: This device is intended exclusively for clinical investigations. Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Consult instructions for use Serial number Pin number For USA audiences only Authorized representative in the European community Manufacturer Warning Type BF applied part (EN 60601-1) Universal Serial Bus (USB) 2.0 port Battery Omnetics (A29100-065) connector interface ports 2016100801 English3 MedtronicTM is a trademark of Medtronic, Inc., registered in the US and other countries. Third party brands are trademarks of their respective owners. FCC Information The following is communications regulation information on the Model 4NR003 External Neurostimulator. FCC ID: LF54NR003 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. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. European Union Compliance Conformit Europenne
(European Conformity) Medtronic declares that this product is in conformity with the essential requirements of Directive 93/42/EEC on Medical Devices. For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual. This product operates at 2.4 GHz with an RF output power of less than 10mW e.i.r.p. English4 2016081001 Table of contents Description 7 Package contents 7 Accessories 7 Device specifications 8 Interactions with other medical equipment 1615 Electromagnetic compatibility declaration 1817 Means of operator and patient protection 2625 Instructions for use 2726 Using the ENS during a research study 2928 Replacing the ENS batteries 3735 Troubleshooting 3937 Device care and storage 4139 Cleaning the ENS 4240 Safety and technical checks 4341 NOTE:
Algorithm Developers: Refer to instructions shipped separately with the Odin Research System Interface Software for specifications in programmatically interfacing with the neurostimulator. Managing Physician and Team: Consult the Odin Configuration Tool Instructions for Use, shipped separately with the Odin Research System Interface Software, and the research study protocol for which this neurostimulator is being used, for details on configuring and running an experiment using the neurostimulator. 2016100801 English5 English6 2016081001 Description The Medtronic Model 4NR003 External Neurostimulator (ENS) is designed to provide concurrent sensing and stimulation of the brain as part of an investigational research study in an acute clinical setting. It is intended for use only under the supervision of trained medical personnel. Package contents ENS Product literature Accessories None 2016100801 English7 Device specifications The Medtronic Model 4NR003 External Neurostimulator (ENS) (Figure 1 and Figure 2) is a programmable device that can be configured to collect neurological signals and provide stimulation using human use surface and depth leads that have been approved per the research study protocol. The ENS is capable of interfacing with up to 256 electrode contacts. The ENS can sense time-domain signals of at least 0.7 Vrms for frequencies between 12-400Hz and at least 4.3671*x^(-0.736) Vrms for frequencies between 0.5-12Hz (where x is frequency in Hz). Up to four stimulation patterns can be configureda for concurrent deliveryb, each with independently controlled parameters and targeted to a specific collection of anode-cathode electrode pairs. Each stimulation pattern can be configured to start at a future point in time and can run indefinitely until a request is made to terminate the stimulation. a Interlocks and out-of-regulation detection will prevent the use of some parameter combinations. b When the system receives a request to deliver multiple stimulation patterns simultaneously, the stimulation pulse may be dithered in order to ensure that delivered stimulation amplitudes are within designed tolerance limits. Delivering multiple stimulation pulses simultaneously to multiple channels may result in stimulation amplitudes that are different from those requested. English8 2016081001 Light-Emitting Diodes (LEDs) USB Port Power Button Pin Resets
(DO NOT USE Medtronic Use ONLY) Figure 1. Model 4NR003 ENS (rear bezel with USB connection interface shown). Lead Connection Figure 2. Model 4NR003 ENS (front bezel with lead connection interfaces shown). Interfaces 2016100801 English9 Table 1. Physical characteristics of the Model 4NR003 ENSa Description Length Width Thickness Weight (without batteries) Universal Serial Bus port Lead Interface Connector jack Wireless Communication Interface Value 5.01 in (127.25 mm) 4.94 in (125.48 mm) 2.11 in (53.59 mm) 509.0 g (18.0 oz) USB Mini-B Omnetics A29100-065 (x 4)b 2.4 GHz WiFibc a All measurements are approximate. b The connector interfaces support connection to lead adapters designed for clinical leads commonly used in Epilepsy Monitoring Units. c Connection interface is limited to a single point-to-point connection with an authenticated device, and communications are encrypted. Table 2. Electrical specifications for the Model 4NR003 ENS Description Nominal Operating Voltage Maximum Voltage Nominal Operating Current Maximum Current Nominal Operating Power Value 4.5V DC 5V DC 250 mA 1.5 A (continuously fused) 1.125 W English10 2016081001 Description Power Source Battery Life Operating Type Degree of protection against electrical shock Ingress protection Case material Automatic shut off Automatic stimulation terminationb Battery level Connection Status Stimulation Status Table 3. ENS electrical and operating characteristics Value AA Lithium batteries (quantity 3) 20 hours minimuma Continuous Type BF IPX0 normal equipment
(1) Polycarbonate/ABS blend plastic resin
(2) Cycoloy C2950 Polycarbonate/acrylonitrile butadiene styrene (PC/ABS) Loss of WiFi connection to controlling computer
(3) Santoprene 211-45 thermoplastic vulcanizate Configurable inactivity timer that upon expiration powers down the device USB cable disconnected Surface LEDs (Figure 1) indicate battery level:
Green Normal Orange Less than 20% battery life remaining Red Batteries depleted, replacement needed Surface LEDs (Figure 1) indicate connection status:
Flashing Colorc Disconnected/Connecting Solid Color Connected Surface LEDs (Figure 1) indicate stimulation state:
Blue Stimulation being delivered Other Color No stimulation a Battery life is based on continuous stimulation driven over a WiFi connection by computational algorithms running on a controlling computer to eight pairs of electrodes with a 1000 load impedance with the following energy characteristics: Amp = 4mA, PW = 300 s, Rate = 400 Hz, while sensing on four differential channels at 1000 Hz. b The ENS will terminate the administration of stimulation upon the detection of a dropped connection with the controlling computer (defined as 1000ms of lost communications). c Displayed color is specific to the battery level of the ENS at the given time. For example, when connecting to an ENS that has sufficient battery power, the LEDs will flash in green. 2016100801 English11 Comment [BZ1]: IhadthoughtthiswouldneedtochangebutIdontthink sonowthatIreadthisareyoucomfortable?
PulseWidth(s) Amplitude FPULSE (Hz)
...
#Pulses PulseTrainCycleDuration pulse train Figure 3. Illustration of configurable characteristics of a stimulation patterns Table 4. Operating parameters for a stimulation patterns pulse train for the Model 4NR003 ENS Operating Parameter Amplitudeb Pulse Width Pulse Frequency (FPULSE) Number of Pulses Pulse Train Cycle Duration Operating Range and Resolutiona 4-256A, with 4A resolution 0.25-8.00mA, with 50A resolution 130-12270s, with 10s resolution 153mHz-1,000,000mHz0.15-5000Hz,, with 1mHz100s resolution 1-511 pulses, with 1 pulse resolution Maximum of 10 seconds, programmable to 1mHz resolution50-1000ms, with 50ms resolution English12 2016081001 a Interlocks and excessive impedance between electrodes will prevent the use or delivery of some parameter combinations. b Step increments/decrements of amplitude are monotonic, and amplitudes delivered at a tolerance of +/- 120.0%. Table 5. Other operating stimulation parameters for the Model 4NR003 ENS Operating Parameter Global Amplitude Limit
(per stimulation channel) Rangea 4uA Maximumb a Interlocks and excessive impedance between electrodes will prevent the use or delivery of some parameter combinations. b Maximum will be set to the Shannon McCreery safe charge density limit (k=1.5) using the surface area of the stimulation channel. Table 6. Operating sense acquisition parameters for the Model 4NR003 ENS High Pass Filter Low Pass Filter 2 Programmable Parameter Low Pass Filter 1 Range and Defaults 50Hz, 100Hz, 450800Hz
(Default: 800Hz450Hz) 100Hz, 350Hz, 1700Hz
(Default: 1700Hz) 0.05Hz, 0.5Hz, or 2.5Hz
(Default: 0.5Hz)0.85Hz 250Hz, 500Hz, 1000Hz
(Default: 1000Hz) 1a, 2, or 4, 8b
(Default: 2) a Only permitted when operating over a USB connection b Only supported when 128 channels or less are defined Samples per Packet Sampling Rate 2016100801 English13 Formatted: Indent: Left: 0.06"
Formatted: Left English14 2016081001 2016100801 English15 Interactions with other medical equipment In the clinical environment for which the ENS is intended for use, there are other equipment, including medical equipment, whose functional performance can be affected by the presence and use of this device. The ENS will produce a stimulation pulse on specified electrodes. This signal will disrupt neurological recordings for the duration of the stimulation period. Once stimulation ceases, neurological recordings return to baseline behavior. Connections of the ENS to the controlling computer, including USB 2.0 and WiFi, will produce emissions that could have an adverse effect on the performance of other nearby equipment. Caution: The device is not certified for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. The consequences of using the device near flammable atmospheres are unknown. Caution: Do not use the device in the proximity of equipment that generates electromagnetic interference (EMI). Sources of EMI may result in (a) operational changes to the neurostimulator, causing it to turn on or off, or to reset to power-on-reset (POR) settings, and (b) a momentary increase in stimulation or intermittent stimulation, effects that may be observable by the patient. Caution: This device should not be used in proximity to magnetic resonance imaging (MRI) equipment. The consequences of exposing the device to MRI equipment are unknown. English16 2016081001 Description of leads tested for compatibility The Model 4NR003 ENS has been tested and is compatible with the following leads and extensions:
Ad-Tech Medical o SD08R-SP10X-000: 8-contact depth; 10mm spacing (lead) o L-SRL-8DIN: 8-contact, Cambrio extension cable o IG64C-SP10X-0TB: 64-contact, single-tail LTM grid (lead) o L-SRL-64BDIN: 64-contact, Cambrio extension cable 2016100801 English17 Electromagnetic compatibility declaration Tables 7, 8, 9, and 10 apply to the Model 4NR003 ENS. Table 7. Guidance and manufacturers declaration electromagnetic emissions The Model 4NR003 ENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 4NR003 ENS should ensure that it is used in such an environment. Emissions Test Compliance Group 1 Class A Not applicable for a battery-
powered device Not applicable for a battery-
powered device Radio-frequency
(RF) emissions CISPR 11(EN 50511) RF emissions CISPR 11 (EN 50511) Harmonic Emissions EN 61000-3-2 Voltage fluctuations/flicker emissions EN61000-3-3 English18 Electromagnetic environment guidance The model 4NR003 ENS uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Model 4NR003 ENS is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. The Model 4NR003 ENS is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. 2016081001 Table 8. Guidance and manufacturers declaration electromagnetic immunity The Model 4NR003 ENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 4NR003 ENS should ensure that it is used in such an environment. Immunity Test EN 60601 test level Compliance level Electrostatic discharge (ESD):
EN 61000-4-2 Electrical fast transient/burst:
EN 61000-4-4 Surge:
EN 61000-4-5 6kV contact 8kV air 2kV for power supply lines 1kV for input/output lines 1kV line(s) to line(s) 2kV line(s) to earth 2kV, 4kV, 6kV contact 2kV, 4kV, 8kV air 2kV for power supply lines 1kV for input/output lines 1kV differential mode 2kV common mode Electromagnetic environment guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 2016100801 English19 Electromagnetic environment guidance Mains power quality should be that of a typical commercial or hospital environment. Immunity Test EN 60601 test level Compliance level Voltage dips, short interruptions and voltage variations on power supply input lines:
EN 61000-4-11
<5% UT
(>95% dip in UT ) for 0,5 cycle 40% UT (60%
dip in UT ) for 5 cycles 70% UT (30%
dip in UT ) for 25 cycles
<5% UT
(>95% dip in UT ) for 5 s 30 A/m
<5% UT
(>95% dip in UT ) for 0,5 cycle 40% UT (60%
dip in UT ) for 5 cycles 70% UT (30%
dip in UT ) for 25 cycles
<5% UT
(>95% dip in UT ) for 5 s 30 A/m Power frequency
(50/60 Hz) magnetic field EN 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. English20 2016081001 2016100801 English21 Table 9. Guidance and manufacturers declaration electromagnetic immunity Compliance level 3 Vrms 3 V/m EN 60601 test level 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz The Model 4NR003 ENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 4NR003 ENS should ensure that it is used in such an environment. Immunity Test Conducted RF EN 61000-4-6 Radiated RF EN 61000-4-3 Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model 4NR003 ENS, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b English22 2016081001 EN 60601 test level Compliance level Electromagnetic environment guidance Immunity Test NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengthsfrom fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 4NR003 ENS is used exceeds the applicable RF compliance level above, the Model 4NR003 ENS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 4RNR003 ENS. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 2016100801 English23 Table 10. Recommended separation distances between portable and mobile RF communications equipment and the Model 4NR003 ENS The Model 4NR003 ENS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 4NR003 ENS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model 4NR003 ENS as recommended below, according to the maximum output power of the communications equipment. Separation distance according to transmitter Power Output Rated maximum output power of transmitter W 0,01 0,1 1 10 100 d = 3.5 P 0,35 1,1 3,5 11 35 150 kHz to 80 MHz outside ISM bands 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2 P d = 1.2 P D = 2.3 P
(meters) 1,2 3,8 12 38 120 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. NOTE 3 The recommended separation distances between portable and mobile radio-
frequency (RF) communications equipment are not applicable to the equipment provided by Medtronic that have been identified as a programming component used in conjunction with the Model 4RNR003 ENS. English24 2016081001 2016100801 English25 Means of operator and patient protection The ENS is designed with means of protection to ensure the safety of both the patient and operator during use (per EN 60601-1), including when it is connected to a controlling computer via USB 2.0 or WiFi. The ENS is internally powered portable medical electrical (ME) equipment when it is not USB-connected to a controlling computer. The USB connection from the controlling computer powers the devices USB port, so the device is considered Class I medical electrical equipment in this configuration. Table 11. Means of operator and patient protections provided by Model 4NR003 ME Equipment Classification Operator Protection(s) ENS Internally Powered Not applicable no connection to supply mains ENS specified for use only with USB cables up to 3 meters in length that support electrical isolation from voltages up to 240 V
(e.g. IFTOOLS ISOUSB-Cable-M). Class I English26 Patient Protection(s)
(1) Reverse battery protection on battery terminals
(2) AC-coupling of output signals to patient, preventing DC current to patient
(1) ESD protection (TVS diodes) on the USB circuitry provides protection up to15 kV
(contact) and 30kV (air).
(2) AC-coupling of output signals to patient, preventing DC current 2016081001 Instructions for use The ENS is used to collect neurological signals and deliver stimulation energy upon request in support of clinical research in an acute, clinical environment. Caution: Do not modify this equipment. Modification of this equipment can result in damage to the device, causing the device to malfunction or become unusable. Caution: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Caution: Use of transducers or cables, other than those specified in this document, is not recommended as use of these components may result in increased emissions or decreased immunity of the ENS. Caution: To avoid the risk of electric shock, ensure that any equipment connected directly to the ENS is only connected to supply mains with protective earth. Caution: Secure the device at all times so as to prevent blunt impacts to the device (e.g. from accidental drops). Blunt impact trauma to the device may result in device malfunction, including unexpected stimulation performance. Caution: Do not touch the pins on the ENSs lead connection interfaces, especially while also in contact with the patient. Static charges can discharge to the patient, resulting in potential harm. 2016100801 English27 Caution: Do not touch the pins on the ENSs lead connection interfaces or put the pins in contact with metal objects. In addition, use care when transporting the ENS in static-prone areas (e.g. carpeted floors). If the ENS is connected to implanted patient leads, static charge discharged to the pins may pass through the leads and cause damage to patient tissue. Caution: Use the ENS only with equipment that is delivered with the device or is otherwise specified as compatible. Caution: Consult with assigned IT support personnel prior to configuring a communication session using WiFi. Wireless performance will vary based on the environment. It is recommended that the ENS be setup for WiFi communications on a channel identified by IT support personnel as having the most available bandwidth and as being least likely to interfere with other ENS or medical devices being used in the area. Note: Before placing the ENS into operation, ensure the ENS has had time to adjust to the current temperature and environment. English28 2016081001 Using the ENS during a research study Ensure the ENS is powered on and then connect to it from the controlling computer. Follow the instructions on setting up communications with the controlling computer that are contained in the applicable research study protocol. Inserting batteries into the ENS See section Replacing the ENS batteriesReplacing the ENS batteries for instructions. 2016100801 English29 Connecting the USB connector cable to the ENS When used during a research study, the ENS is connected to a controlling computer equipped with the Odin Interface Software either via a USB connection or WiFi connection. The USB connector cable can be connected to the ENS to enable a USB connection to the controlling computer. Follow the instructions on setting up communications with the controlling computer that are contained in the applicable research study protocol. Caution: Use only USB cables up to 3 meters in length that support electrical isolation from voltages up to 240 V (e.g. IFTOOLS ISOUSB-Cable-M). Use of unsupported cables can cause damage to electronic components of the device and may cause an electrical shock to the patient if connected. Caution: USB is designed as a secondary communication mechanism to WiFi and should only be used when WiFi performance is inadequate for the needs of the experiment. Caution: Disconnect the controlling computer from wall power while USB-connected to the ENS. Failure to disconnect may cause a transfer of energy to the patient in the event of a power surge to the wall outlet. Matching the keyed slots of the USB Mini-B connector plug and the USB Mini-B connector jack, push the plug end of the connector cable fully into the USB Mini-B connector jack on the ENS. Failure to fully seat the USB connector plug may result in intermittent connectivity Note: Attempting to connect the USB connector cable while the ENS is currently connected to the controlling computer via WiFi will result in the automatic re-
establishment of the connection using USB. If sensing was enabled at the time of this action, neurological sense data will no longer be collected until the reconnection sequence is complete. English30
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2016081001 Connecting the lead interface adapter cables to the ENS Caution: Do not pull on the cable. Pulling on the cable may break a wire or dislodge the lead. A broken wire or dislodged lead may result in loss of stimulation and may require surgery to replace the lead. Caution: Do not use the ENS with unsupported clinical EEG equipment. The ENS is capable of operating with EEG monitoring hardware that supports an input voltage of up to 17 V without damage or clipping, a minimum input impedance of 50 k, and isolation from voltages up to 240 V. Caution: Use only the Blackrock Microsystems Adapter PN9770
#A0263 revision 2.00 with the ENS. Other lead interface adapter cables have not been tested with this device, and use of these cables may result in unexpected device performance. Matching the keyed slots of the connector plug and the Omnetics connector jack, slowly guide the plug end of the adapter cable fully into the jack, using a side-to-side motion. The adapter plug has bi-lobe keys that ensure the plug is oriented correctly, so undue force to fully seat the plug is not necessary. After plugging in the adapter plug, perform a visual inspection to ensure the plug is fully seated (i.e. no gaps on the metal shrouds between the mating connectors). Notes:
If the Omnetics connector jack will not easily receive the adapter plug, perform a visual magnified examination of the plug and connector jack to ensure there are no bent pins and that pin alignment is consistent in each row. The ENS contains four Omnetics connector jacks labeled A-D. To avoid confusion when configuring sense and stimulation on electrodes during an experiment, make particular note of the interfacing electrodes that are connected to each Omnetics connector jack. 2016100801 English31 Configuring the ENS for sensing and stimulation Caution: Evaluate the safety of stimulation to intended lead contacts prior to commencing with the research study. This can be accomplished by incrementing stimulation energy to each intended channel to observe patient side effects until side effects are observed or the intended stimulation amplitude target is reached. Caution: Avoid excessive stimulation. There is a potential risk of brain tissue damage from high amplitude and wide pulse width parameter settings. The ODIN Configuration Tool Instructions for Use, shipped separately with the Odin Research System Interface Software, provides instructions for developing a sense and stimulation channel configuration file that can be used to configure the device for sensing and stimulation during a research study. Consult this documentation and the associated research study protocol for details on configuring and running an experiment using the ENS. To power on the ENS:
Press and hold the power button on the upper surface of the ENS (Figure 1) until LEDs surrounding the button begin to rotate in white color (i.e. about two seconds) to indicate the device is initializing. English32 2016081001 Notes:
For sensing applications using a common reference, connect all Ref lines from each Omnetics connection jack (A-D) (Figure 4) that is in use and connect the combined signal to the reference input on the jackbox. All Omnetics connection jacks used must have the Ref lines connected for sensing to function as designed. Identify the Emergency Stop Esc key location on the controlling computer prior to starting an experiment. In the event that stimulation needs to be terminated during the experiment, this Esc key, referenced in the associated research study protocol, will terminate stimulation delivery when pressed. Once connected to a controlling computer over USB, the ENS will refuse connection requests using WiFi. To enable the ENS to connect using WiFi once a USB session has been established, power-cycle the ENS. Take note of stored configurations, as power-cycling the ENS will reset its configuration. Figure 4. Omnetics A29100-065 connector jack as viewed with the ENS top side up. Pin 65 (labeled) is the Ref line. 2016100801 English33 English34 2016081001 Terminating stimulation delivery The delivery of stimulation, including stimulation programmed for delivery in the future, can be terminated upon request. One method is by pressing the Emergency Stop key. The Emergency Stop key is located on the controlling computer as the Esc key. Take note of this keyse Emergency Stop key location, referenced in the associated research study protocol, prior to starting an experiment. To terminate the administration of stimulation:
Press the Emergency Stop key on the controlling computer. Consult the research study protocol for detailed instructions. OR Press the power button on the upper surface of the ENS (Figure 1). Caution: Take note of stored configuration settings before turning off power to the ENS. Interruption of power to the ENS will cause stored configurations, including those for sensing and stimulation, to reset. Formatted: Font: Not Bold Formatted: Not Raised by / Lowered by 2016100801 English35 Disconnecting lead interface adapter cables from the ENS F Caution: Take note of stored configuration settings before turning off power to the ENS. Interruption of power to the ENS will cause stored configurations, including those for sensing and stimulation, to reset. 1. Press the power button on the upper surface of the ENS to turn it off (Figure 1). 2. Disconnect each lead interface adapter cable from the ENS, one at a time. Slowly remove the connector plug using a side-to-side pulling motion until it is released from the jack. English36
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2016081001 Replacing the ENS batteries Replace the ENS batteries before each use and when the batteries are low or depleted. The battery status is displayed by LEDs (Figure 1) that surround the power button on the ENSs top surface. Cautions:
If batteries are replaced during a research study, stored sense and stimulation configuration may not reflect recent configurations. Replace batteries using the correct polarity. Reversing polarity when installing new batteries may result in unexpected device function and/or performance. Do not mix chemistries or brands when replacing batteries. Only use Energizer Ultimate Lithium AA batteries when replacing the ENS batteries. Other battery types, such as Alkaline or rechargeable, or batteries from other manufacturers, are not supported and may cause damage to the electronic components of the device. Take note of stored configuration settings before turning off power to the ENS. Interruption of power to the ENS will cause stored configurations, including those for sensing and stimulation, to reset. 1. End the experiment and disconnect the ENS from the controlling computer, if applicable. Consult the applicable research study protocol for instructions on ending the experiment appropriately. 2. Turn off the ENS by pressing the power button, if applicable. 3. Press into each of the battery compartment tabs to release the battery 4. compartment cover (Figure 5). Pull the cover to remove. Insert three new Energizer Ultimate Lithium AA batteries. Correct battery polarity is indicated inside the battery compartment. 5. Replace the battery compartment cover. Notes:
Dispose of depleted batteries according to local requirements. 2016100801 English37 Battery compartment tabs Figure 5. Model 4NR003 ENS (underside surface shown). English38 2016081001 Troubleshooting Intermittent WiFi connections The nature of the environment may produce interference that results in intermittent or no WiFi connection from the ENS to the controlling computer. The following suggestions are recommended to remedy intermittent WiFi connections:
Reduce or eliminate interfering sources, if possible. For example, phones or other personal items may be removed from the room, or supply mains to the controlling computer may be disconnected. Check the WiFi connection on the controlling computer. See the applicable research study protocol for detailed instructions. Move the ENS to a different area of the room where fewer interfering sources are present. Reconnect the ENS using a USB connection. Consult the research study protocol for instructions on configuring this connection. 2016100801 English39 English40 2016081001 Device care and storage Check the battery status of the ENS before each research study. Replace low or depleted batteries. Handle the device and system components with care. Do not drop, strike or step on the device or system components. Do not dismantle or tamper with the device. Store the ENS at room temperature. Avoid extreme hot or cold temperatures Upon completion of the research study (or if device is no longer operating as and direct sunlight. expected), contact the clinical study site coordinator to return the device. Do not dispose of devices. 2016100801 English41 Cleaning the ENS Cautions:
Avoid application of any chemicals to the batteries underneath the battery compartment door. The application of moisture to the batteries may cause damage to electronic components. The device and system components are not waterproof. Do not allow moisture to get inside the device or system components. procedures identified in this document do not protect against contamination by blood-borne pathogens or other potentially infectious materials. Before cleaning the device, be aware that the cleaning 1. Use a damp cloth with a 1:10 dilution of sodium hypochlorite or a 70%
isopropyl alcohol wipe to clean the exterior of the ENS. 2. Wipe the ENS with a clean cloth dampened with clean water. 3. Dry with a clean cloth. Notes:
To wipe the recess areas around the battery compartment door, it may be necessary to remove the battery compartment door. The battery contacts may be cleaned periodically with a cotton swab dampened with a solution containing up to 70% isopropyl alcohol. Do not use a pencil eraser or sandpaper. English42 2016081001 Safety and technical checks Periodic safety and technical checks or periodic maintenance of the ENS are not required. The ENS contains no serviceable components. If the ENS is nonfunctional or otherwise requires repair or replacement, contact the clinical study site coordinator for instructions to return the unit. 2016100801 English43 Manufacturer Medtronic, Inc. 7000 Central Ave Minneapolis, MN 55432 USA www.medtronic.com Tel. 1-763-505-5000 Fax 1-763-505-1000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31, Case Postale 84 CH-1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Medtronic, Inc. 2016 All Rights Reserved M966503A001 Rev BC Zingsheim, Brandon Page 30: [1] Comment [BZ2]
Daleisthisstilltrueoristheusergoingtoberequiredtoreenablesensing?
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frequency | equipment class | purpose | ||
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1 | 2017-01-19 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2017-01-19
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1 | Applicant's complete, legal business name |
Medtronic, Inc.
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1 | FCC Registration Number (FRN) |
0008250839
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1 | Physical Address |
8200 Coral Sea Street NE
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1 |
Mounds View, Minnesota 55112
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1 |
United States
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app s | TCB Information | |||||
1 | TCB Application Email Address |
g******@nwemc.com
|
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 | Grantee Code |
LF5
|
||||
1 | Equipment Product Code |
4NR003
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G**** G********
|
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1 | Title |
Sr. RF Regulatory Program Manager
|
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1 | Telephone Number |
763-5********
|
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1 | Fax Number |
651-3********
|
||||
1 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 4NR003 | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be collocated or operating in conjunction with any other antenna or transmitter within a host device, except in accordance with FCC multi-transmitter product procedures. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Element Materials Technology Minneapolis
|
||||
1 | Name |
R****** W******
|
||||
1 | Telephone Number |
503-8********
|
||||
1 | Fax Number |
503-8********
|
||||
1 |
r******@element.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0060000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC