Cochlear Implants. I 100 detector box. User Manual. AW9750_4.0 (English)

Transcription

1 Cochlear Implants I 100 detector box User Manual AW9750_4.0 (English)

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3 Table of contents 1. Table of contents 2. INTRODUCTION 3 3. USE OF THE I 100 DETECTOR BOX 5 4. GETTING STARTED 6 I 100 detector box setup 6 5. DETAILED DESCRIPTION 8 Device features 8 Input and output interfaces 8 Device function 10 Performing a measurement 12 Simulated IFT scenarios 14 Simulated Auditory Nerve Response Telemetry (ART) 16 Training and troubleshooting tool GENERAL PRECAUTIONS AND WARNINGS 18 General precautions and warnings CARE AND MAINTENANCE TROUBLESHOOTING TECHNICAL DATA 21 I 100 detector box 21 Symbols APPENDICES 23 Disposal 23 Warranty 23 Manufacturer address CONTACT MED EL 24 1

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5 Introduction 2. Introduction The I 100 detector box is not a medical device. It is an optional table-top device that can be used as a training and visualization tool. The I 100 detector box is not an accessory to the MED EL Cochlear Implant System, i.e. it is not required for the proper function of the implant system. Furthermore, its functions do not provide either treatment or a diagnosis. It can optionally be used to detect communication problems between audio processor and implant by confirming the function of audio processors. The I 100 detector box is designed for the following functions: Simulate the electrical stimulation pulses of a cochlear implant Simulate a cochlear implant during telemetry measurements performed in training sessions without the patient Confirmation of function of external components of the MED EL Cochlear Implant (CI) System IMPORTANT: The I 100 detector box is not intended for use on patients. This manual describes the features and use of the I 100 detector box. Read this manual entirely before using the I 100 detector box for the first time. The user should be familiar with the use of the MED EL application software. The I 100 detector box is compatible with all configurations of external audio processors of the MED EL Cochlear Implant System designed for use with the PULSARci 100, SONATAti 100, Mi1000 CONCERTO (hereafter referred to as CONCERTO) and Mi1200 SYNCHRONY (hereafter referred to as SYNCHRONY) implants. 3

6 Introduction Table 1 shows the combinations of software, MED EL hardware interface system and the corresponding coil that can be used with the I 100 detector box: MED-EL hardware interface system Software Coil MAX MAESTRO 5.0 and higher MAX Coil MAX Coil S MAESTRO 3.0 up to MAESTRO 4.1 DIB II DIB II I 100 Coil CI.STUDIO DIB1.1 CI.STUDIO DIB Coil PULSAR Table 1 Software and hardware compatibility for telemetry measurements For external components of the MED EL Cochlear Implant System including a coil and an audio processor, all combinations including either a COMT+ P, D Coil or DL-Coil can be used with the I 100 detector box. Furthermore, the RONDO audio processor can also be used with the I 100 detector box. Table 2 gives an overview of the combinations of the external components: Coil Audio Processor COMT+ P TEMPO+ / OPUS 1 / OPUS 2 / DUET 1 / DUET 2 D Coil TEMPO+ / OPUS 1 / OPUS 2 / DUET 1 / DUET 2 / SONNET RONDO RONDO DL-Coil SONNET Table 2 Compatibility between external audio processors and I 100 detector box Using one of these combinations requires an oscilloscope or a signal analyzer to enable the visualization of the simulated stimulation pulses. Please contact your nearest MED EL representative or MED EL Headquarters with any additional questions you may have. 4

7 Use of the I 100 detector box 3. Use of the I 100 detector box The I 100 detector box is an optional electronic device to illustrate electronic key features of the MED EL Cochlear Implants PULSARci 100, SONATAti 100, CONCERTO and SYNCHRONY. The I 100 detector box can be used to visualize current pulses that are similar to stimulation pulses generated by a cochlear implant PULSARci 100, SONATAti 100, CONCERTO and SYNCHRONY. It can also optionally be used as a tool for troubleshooting and to confirm the function of external components of the MED EL Cochlear Implant System. The I 100 detector box is intended to be used by clinical engineers and trained clinical staff exclusively. The I 100 detector box is not intended to be used by the patient. The I 100 detector box must not be used as a tool to localize or detect implant failures. The I 100 detector box is not intended for medical, clinical or human use. 5

8 Getting started 4. Getting started I 100 DETECTOR BOX SETUP pole D-SUB socket (future option) 2 S1 Switch Impedance selector 3 Probe Pins 2 1 Fig. 1 I 100 detector box, left side S2 Switch Channel selector: The selected channel is routed to the BNC output socket 5 Area to place the coil (inductive link) 6 BNC output socket 6 Fig. 2 I 100 detector box, right side 6

9 Getting started 1 15 pole D-SUB socket: this is a future option. This socket is not intended to be used at this time and is designed to accommodate future functionality. 2 Switch S1 Impedance selector: One out of three positions can be selected: OK, HI and SC1 2 ART: OK: normal impedance on all 12 channels is simulated HI: a high impedance on channel 1 is simulated SC1 2 ART: This selection has two functions: SC1 2: a short circuit between channel 1 and channel 2 is simulated when performing IFT (Impedance Field Telemetry) measurements with the MED EL application software or observing the stimulation pulses on the oscilloscope) ART (Auditory Nerve Response Telemetry): simulating an ART measurement when ART task is performed in the MED EL application software 3 Probe Pins: 13 Probe pins are mounted onto the I 100 detector box: 12 signal pins and one ground pin. These pins can be used to connect the I 100 detector box to an oscilloscope 4 Switch S2 Channel selector: one channel out of 12 can be selected, the signal on this channel is routed to the BNC output socket and can be observed e.g. on the oscilloscope 5 Area to place the coil: Every coil specified in the INTRODUCTION section can be used with the I 100 detector box. The coil is automatically held in position by magnetic attraction when placing the coil onto the I 100 detector box 6 BNC output socket: the signal that is selected with the channel selector switch S2 is present on the BNC output and can be observed on an oscilloscope A more detailed description of the input/output interfaces can be found in the next section. 7

10 Detailed description 5. Detailed description DEVICE FEATURES The I 100 detector box does not contain an independent power source. It is powered via inductive link which generates the supply voltage from the RF signal transmitted by the attached audio processor coil. Removing the coil from the I 100 detector box also removes the power supply and terminates the operation of the I 100 detector box. INPUT AND OUTPUT INTERFACES Bidirectional digital data interface / inductive link The I 100 detector box is compatible with data formats used in the MED EL Cochlear Implant System. Data can be transmitted via a coil that is placed onto the designated area on the I 100 detector box. BNC socket The I 100 detector box has a BNC socket to pick up the signals from the 12 simulated active electrode channels. The signal that is present at the BNC socket can be selected with the S2 switch. The length of the BNC cable used to connect the I 100 detector box to an oscilloscope or a signal analyzer shall not exceed 1 meter. Probe pins The I 100 detector box features 13 probe pins (12 signal pins and one ground pin) to connect oscilloscope probes to each of the 12 simulated active electrode channels. Fig Signal pins and one ground pin 8

11 Detailed description Controls The I 100 detector box has two controls: the impedance selector (S1) and the channel selector (S2). The impedance selector is a rotary switch to change between different selectable load impedances on channel 1 and it connects the evoked compound action potentials (ECAP) simulator to the stimulation and recording channels 1 and 2. Fig. 4 Impedance selector switch S1 The channel selector is a rotary switch to select the signal deriving from any one of the 12 simulated active electrode channels. This signal is then picked up by the BNC socket. Fig. 5 Channel selector switch S2 9

12 Detailed description Indicator functions The I 100 detector box does not display any information. To visualize stimulation pulses generated by the I 100 detector box, an oscilloscope or a signal analyzer has to be connected with a BNC cable or with the oscilloscope probe pins. Single-channel and multi-channel (up to 12 channels) oscilloscopes or signal analyzers can be used. To display telemetry results, please refer to section Performing a measurement. Requirements An oscilloscope or signal analyzer is needed to enable the visualization of the signal. A standard oscilloscope should be used. The oscilloscope should have BNC connectors and an input resistance of approximately 1 MΩ (10 6 Ω) in parallel with a capacitance of approximately 20 picofarads. 1 channel-oscilloscopes/ signal analyzers can be used as well as oscilloscopes/signal analyzers with up to 12 monitoring channels. Preferably standard oscilloscope probes should be used, matched with the input capacitance of the oscilloscope. Attaching the I 100 detector box to an external inductive coil of the implant system While in use, the I 100 detector box is attached to an external inductive coil of the implant system such as the DIB II I 100 Coil, the DIB Coil PULSAR, the COMT+ P coil, the D Coil, the DL-Coil or the RONDO. The coil is held in place magnetically on the designated area on the surface of the I 100 detector box. DEVICE FUNCTION Visualization / demonstration of current pulses Any configuration of external components of the cochlear implant system that are compatible with the implants PULSARci 100, SONATAti 100, CONCERTO and SYNCHRONY can be connected to the I 100 detector box as well. To display the stimulation pulses, the output signals of the current sources can be transmitted to an oscilloscope via the probe pins or the BNC output (one out of the 12 channels can be selected with the channel selector switch S2). 10

13 Detailed description Fig. 6 Connection of the I 100 detector box to an oscilloscope via probe pins Fig. 7 Connection of the I 100 detector box to an oscilloscope via BNC socket 11

14 Detailed description Demonstration of telemetry measurement The I 100 detector box can be used to demonstrate measurements of electrode impedances (IFT) and Auditory Nerve Response Telemetry (ART). To perform these measurements, the I 100 detector box is connected to an external telemetry coil and the MED EL application software is used. Troubleshooting The I 100 detector box indicates if configurations of external components of the MAESTRO CI System can communicate with an implant. As long as pulses can be visualized and measurements can be simulated, it is evident that external components enable data communication with the implant. To conclude that external components are defective is not allowed as the I 100 detector box is not a controlled test device. PERFORMING A MEASUREMENT The I 100 detector box simulates the implant attached to the external coil of the implant system. When performing a measurement the external coil has to be positioned on the designated area on the I 100 detector box (see Fig. 8). The coil is held in place by magnetic attraction. Fig. 8 Area on the I 100 detector box to attach the coil To display the signals the I 100 detector box has to be connected to an oscilloscope or a signal analyzer. Up to 12 active electrode channels can be monitored simultaneously when using the I 100 detector box as an implant stimulation dummy to demonstrate stimulation pulses. 12

15 Detailed description To perform IFT and ART measurements, any patient in the MED EL application software data base can be used. In order to avoid mixup of real patient measurement data with measurement data obtained from the I 100 detector box, the MED EL application software does not allow to save measurement data obtained from the I 100 detector box. If no existing patient data is available in the MED EL application software, a new patient can be created: This patient does not represent a real patient and is only used for measurements with the I 100 detector box. When creating a patient, a PULSARci 100 implant has to be selected and the six digit number has to be used as a serial number. A detailed description of how to create a patient can be found in the manual of the MED EL application software. This patient can now be selected and the IFT and ART measurements can be performed as with real patients. IMPORTANT: For safety reasons, data created during these measurements using the I 100 detector box must not be saved. The possible scenarios of the IFT measurement are described below. 13

16 Detailed description SIMULATED IFT SCENARIOS Three scenarios that could occur while performing a telemetry measurement on a real implant can be simulated with the I 100 detector box. With the S1 switch the following three scenarios can be selected. Scenario 1: All electrodes are technically functioning S1 switch position: OK When the patient is selected and the I 100 detector box is connected to a MED-EL hardware interface system (via an appropriate coil), a simulation of an IFT measurement can be performed. Obtained result (displayed by MED EL application software): The status of all electrodes are displayed as OK. The measured voltages of all electrodes are within the measurement range of the system. The telemetrically measured impedances on all channels are within a range of 5 kω R 10 kω. If such a telemetry result is observed during an actual clinical measurement on a patient, this would allow the conclusion that current flow has occurred through all electrodes during the telemetry measurement and thus the electrode is considered technically functioning. Scenario 2: The measured voltage on electrode 1 exceeds the measurement range of the system S1 switch position: HI Obtained result (displayed by MED EL application software): The status of electrode 1 is displayed as HI. This result shows that the impedance of electrode 1 is too high to let enough current flow through the electrode. The statuses of electrodes 2,3,4 12 are displayed as OK. If such a telemetry result is observed during an actual clinical measurement on a patient, this could be due to: an air bubble in the area of electrode contact 1 a faulty wire between the implant and electrode contact 1 above-average growth of bone/connective tissue around electrode 1 in the cochlea 14

17 Detailed description Scenario 3: Short circuit between channels 1 and 2 S1 switch position: SC1-2 ART Obtained result (displayed by MED EL application software): The statuses of electrodes 1 and 2 are displayed as SC-A. This indicates a short circuit between channels 1 and 2. The telemetrically measured load impedances on channels 1 and 2 are within a range of 0.8 kω R 1.8 kω (the impedances of channels 3,4,5 12 are within a range of 5 kω R 10 kω). Voltage Matrix Tab of the MED EL application software, voltages displayed as values (in volts): The value of the element (column 1, row 2) outside the diagonal of the table approximately reaches the value of the diagonal element in the same row (row 2, column 2) of the table. This indicates a short circuit between channel 1 and channel 2. Voltage Matrix Tab of the MED EL application software, voltages displayed as bars: The height of the bar of the element (column 1, row 2) outside the diagonal of the table appears in a height close to 100 %, which is equal to the heights of all bars in the diagonal of the table. This indicates a short circuit between channel 1 and channel 2. If such a telemetry result is observed during an actual clinical measurement on a patient, this would indicate a short circuit between the electrode wires 1 and 2. 15

18 Detailed description SIMULATED AUDITORY NERVE RESPONSE TELEMETRY (ART) S1 switch position ART Performing an ART measurement: The S1 switch on the I 100 detector box is set to SC1-2 ART. In the MED EL application software the ART task is selected. To simulate an ART measurement, please follow the description in your MED EL application software manual. Settings for the ART measurement in the MED EL application software: choose your settings (e.g max amplitude, etc.) in the setup tab of the ART task only electrodes 1 and 2 can serve as stimulating and recording electrodes click the Measure button to display the obtained data of the ART measurement, the Cathodic/Anodic or the Anodic/Cathodic button has to be selected Obtained result (displayed by MED EL application software): A decaying oscillation can be observed as in Fig. 9. Fig. 9 Decaying oscillation of an ART measurement 16

19 Detailed description TRAINING AND TROUBLESHOOTING TOOL The I 100 detector box can be used as a training instrument and troubleshooting tool. By simulating the function of an implant, the I 100 detector box can indicate if configurations of external components of the MED EL Cochlear Implant System can communicate with an implant. As long as pulses can be visualized and measurements can be simulated, it is evident that external components enable data communication with the implant. To conclude that external components are defective is not allowed as the I 100 detector box is not a controlled test device. IMPORTANT Data communication failure with the I 100 detector box does not indicate data communication failure between the audio processor and the implant. 17

20 General precautions and warnings 6. General precautions and warnings IMPORTANT For information about the safe use of the MED EL Cochlear Implant System please refer to the applicable audio processor user manual or contact MED EL. If the I 100 detector box is used in a manner not specified by the manufacturer, the protection provided by the device may be impaired. GENERAL PRECAUTIONS AND WARNINGS The I 100 detector box must not be used for medical, clinical or human use. The I 100 detector must not be used as a tool to localize or detect failures of implants. The I 100 detector box is for indoor use only. The I 100 detector box shall only be used by clinical engineers or trained clinical staff. The I 100 detector box must not be used by the patient. Always handle the I 100 detector box with care to achieve maximum lifetime. Do not open or alter the I 100 detector box. Do not drop the I 100 detector box to avoid damage to the device. The defined operating temperature range for the I 100 detector box is between +18 C and +30 C. Do not expose the I 100 detector box to direct sunlight. Avoid getting the I 100 detector box wet as this may impair its function. Keep the device away from moisture. Do not save data obtained with the I 100 detector box. 18

21 Care and maintenance 7. Care and maintenance Do not clean the I 100 detector box in or under water. Use a damp cloth to gently clean the device. Do not use aggressive cleaning agents. Protect the I 100 detector box from water (see also Chapter 6, General precautions and warnings). Do not try to repair the electronics of the I 100 detector box or open the device. The I 100 detector box does not require regular expert maintenance. The I 100 detector box does not contain any power source, thus no checking of battery status or connection to mains power is necessary. However, for proper functioning of the device it must be assured that the energy supply of the attached audio processor or hardware interface system is working correctly. 19

22 Troubleshooting 8. Troubleshooting IMPORTANT Please also refer to the applicable MED EL audio processor user manual for troubleshooting guidelines for the audio processor. If you suspect a malfunction of the I 100 detector box or if expected results during troubleshooting of external components of a CI-system cannot be obtained, please contact a MED EL representative to investigate the problem. To avoid incorrect measurements, the I 100 detector box can shut down under the following electrostatic discharge events: at a contact discharge of 4 kv and higher at an air discharge of 4 kv and higher at an indirect discharge at a horizontal coupling plane of 4 kv and higher A shutdown of the I 100 detector box requires a restart, which can be achieved by removing the coil from the designated area on the I 100 detector box and placing it back again. 20

23 Technical data 9. Technical data I 100 DETECTOR BOX Dimensions 1 Length: 190 mm Width: 80 mm Height: 50 mm Weight: <500 g Power supply Via inductive link. No separate power supply implemented. Temperature range and humidity Operational temperature: +18 C to +30 C Storage temperature: 20 C to 60 C Relative humidity: 10 % to 93 % Electrical characteristics The device is inductively powered via external coil Internal supply voltage Vmax = 7.2 V 1 typical values 21

24 Technical data SYMBOLS The I 100 detector box is in compliance with directive 2004/108/EC (Electromagnetic Compatibility (EMC)) and 2011/65/EU (restriction of use of hazardous substances (RoHS)) CE mark applied in 2015 Refer to I 100 detector box user manual (mandatory action) Relative humidity Manufacturer Catalogue number Serial number Temperature limit Fragile, handle with care 22

25 Appendices 10. Appendices DISPOSAL We advise to dispose of all external components of your MED-EL Cochlear Implant System by returning them to your local MED-EL subsidiary or distributor. Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserve natural resources. Moreover, proper recycling of the electronic and electrical waste equip ment will ensure safety of human health and environment. WARRANTY Our warranty is in agreement with statutory warranty claims. This warranty exclusively covers product failures; it shall not apply to any MED EL product subjected to physical or electrical abuse or misuse, or operated in any manner inconsistent with the applicable MED EL instructions. Statutory warranty claims shall not be granted unless the registration card is completed and returned to MED EL within three weeks. MANUFACTURER ADDRESS MED EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) office@medel.com 23

26 MED EL Contacts 11. Contact MED EL Please refer to the accompanying Contact Sheet for your local office. 24

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28 MED-EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria 10% -20 C (-4 F) 93% +60 C (+140 F) medel.com