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otometrics ICS Chartr EP 200 Installation And Startup Manual

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ICS Chartr EP 200
Installation and Startup Guide
Doc. No. 7-50-0570-EN/10
Part No. 7-50-05700-EN

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  • Page 1 ICS Chartr EP 200 Installation and Startup Guide Doc. No. 7-50-0570-EN/10 Part No. 7-50-05700-EN...
  • Page 2 Copyright notice © 2009, 2019 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, Otoscan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries. Version release date 2019-08-28 (214597) Technical support Please contact your supplier.

  • Page 3: Table Of Contents

    Table of Contents Introduction Prepare System for Data Collection Prepare Patient for Testing Collect Patient Data Review Collected Data Print a Patient Report Maintenance and Troubleshooting Safety Technical specifications 10 Installation Reference 11 Diagnostic Calibrations Otometrics - ICS Chartr EP 200...
  • Page 4 Otometrics - ICS Chartr EP 200...

  • Page 5: Introduction

    Installation Reference • Diagnostic Calibrations Once you are comfortable with the basics, take the time to explore the extensive capabilities of the ICS Chartr EP 200 sys- tem. Device Description The ICS Chartr EP 200 system with VEMP Monitor incorporates hardware enabling the capabilities of the two predecessor devices to be offered as a single device.

  • Page 6: Prepare System For Data Collection

    For this reason, the examination methods are men- tioned only to the degree that is necessary for a correct, safe application of the ICS Chartr EP 200 system. Other Resources...
  • Page 7 (i.e., a work ID) 3. Click Add Operator Dialog Box B. Click to add your name to the operator list and display the ICS Chartr EP 200 Main Window. C. Go to 2.3Step 3 Study Main Window ► Otometrics - ICS Chartr EP 200...
  • Page 8 2 Prepare System for Data Collection Study Main Window Step 3 A. Review each area of the ICS Chartr EP 200 Main Window and its function. ICS Chartr EP 200 Main Window Areas displayed with or without Function/Purpose patient selected...
  • Page 9 Waveform bank numbers Select waveform by number Waveform page comments box Type comments to be saved with waveforms F1 Help B. Click for additional information. C. Go to 2.4Step 4 Set up Patient Record ► Otometrics - ICS Chartr EP 200...
  • Page 10 Identification – (i.e., a work ID) Gender 2. Select the [required]. Add Patient Information Dialog Box C. Click to create a patient record. ► D. Go to 2.5Step 5 Select Referring Physician and Facility Otometrics - ICS Chartr EP 200...
  • Page 11 6.6Step 29 Set up New Referring Facility ► 4. Click Edit Patient Information Dialog Box C. Click to save the information on both tabs. D. Go to 3.1Step 6 Patient Preparation ► Otometrics - ICS Chartr EP 200...

  • Page 12: Prepare Patient For Testing

    Prepare the skin at the electrode site in order to obtain clean, accurate recordings. To prepare each site, use electrode prep on a cotton swab or gauze and scrub the area where the electrode will be placed. Remember the electrode is not Otometrics - ICS Chartr EP 200...
  • Page 13 Position ICS Chartr EP 200 Preamp on the Patient The ICS Chartr EP 200 system is supplied with a lanyard and a shoulder harness. The lanyard is used to hang the preamp around the patient’s neck and rest on the patient’s chest. However, if the patient has an implantable device (e.g., pace- maker), this is not the best option as the pacemaker may add noise into the EP tracings.
  • Page 14 Below are proper connection of electrode wires into the preamplifier for 1 and 2 channel recordings for ABR, ECochG and VEMP. These electrode montages are commonly used for data collection. These are not exclusive and other montages may be appropriate for data collection. Otometrics - ICS Chartr EP 200...
  • Page 15 When performing bone conduction ABR, always place the reference electrode and the ground on the front of the earlobe. Caution If an alternate montage is used with Electrode Switching ON, the data collected will be inaccurate. • Otometrics - ICS Chartr EP 200...
  • Page 16 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 17 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 18 There may be a small amount of residual electrode gel on the tympanic membrane. The tympanic membrane may be inflamed where the electrode was placed. The gel residue will dry and exude from the ear canal. The tympanic mem- brane inflammation should abate within a few hours. Otometrics - ICS Chartr EP 200...
  • Page 19 Red tubing goes to the right insert phone and blue tubing to the left insert phone. Attach the electrode leadwire to the patient cable. See montages for electrode placement options. Note ► for continuation of this electrode placement. • Otometrics - ICS Chartr EP 200...
  • Page 20 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 21 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 22 The SCM should bulge. Place the electrode on the middle and most bulbous part of the SCM. The right and left SCM electrodes should be symmetrical (at the same level) on the patient's neck. 3.3 Step 8 VEMP Monitor ► Otometrics - ICS Chartr EP 200...
  • Page 23 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 24 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 25 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 26 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 27 3 Prepare Patient for Testing Otometrics - ICS Chartr EP 200...
  • Page 28 EMG activity." The ICS Chartr EP 200 VEMP MONITOR assesses the level of tonic EMG and displays if the level is adequate or inadequate. 1 Akin FW, Murnane OD, Panus PC et al. (2004) The influence of voluntary tonic EMG level on the vestibular-evoked myo- genic potential.
  • Page 29 Good (green) – EMG level is between the value and the value High (amber) – EMG level is above value Connect VEMP Monitor to Preamp Go to 3.4 Step 9 Connect Bone Conduction Transducer ► Otometrics - ICS Chartr EP 200...
  • Page 30 Wave V. Wave I is not always present in the ipsilateral response. Listening Check Perform a listening check to verify that the output of the bone oscillator is accurate. See Listening Check ► Estab- lish Normal Hearing Level Thresholds ► Otometrics - ICS Chartr EP 200...
  • Page 31 Start at a moderate level, 30 dB nHL. Vibration at high intensities from the oscillator can wake a patient. Do not exceed 55 dB nHL, this will overdrive the oscillator and cause stimulus artifact in the recording that could be misinterpreted as a true response. ► C. Go to 3.5 Step 10 Connect Insert Earphones Otometrics - ICS Chartr EP 200...
  • Page 32 Incorrect placement of eartips can result in poor quality recordings and/or increased thresholds. Double check that the earphones are placed in the correct ears so that test results are not assigned to the wrong ear. Red = Right ear, Blue = Left ear. Otometrics - ICS Chartr EP 200...
  • Page 33 Make sure there is an impedance reading for each channel with electrodes connected and the ground. – Adjust the electrodes as needed. Impedance Test Dialog Box C. Click to stop the impedance test. D. Go to 4.1Step 12 Select a Protocol ► Otometrics - ICS Chartr EP 200...

  • Page 34: Collect Patient Data

    Main Window. Click on a + sign to expand a list. Click on a - sign to collapse a list. Procedure (A). The ICS Chartr EP 200 default (ICS- supplied) procedures (A) are: Selected protocol (B). (Auditory Brainstem...
  • Page 35 Modify, and Delete Protocols ► to modify a trial setting parameter for use on more than one patient. Settings Tab Settings Tab Pop-up Menu D. Go to 4.4Step 15 Create, Modify, and Delete Protocols ► Otometrics - ICS Chartr EP 200...
  • Page 36 • Only Channel 1 options are available in the ASSR software. Save D. Click to save the modified parameters for the ASSR protocol. ► E. Go to 4.4Step 15 Create, Modify, and Delete Protocols Otometrics - ICS Chartr EP 200...
  • Page 37 Trial setting parameters may be modified for all EP procedures. In order to create, modify, or delete a protocol, a patient file must be opened. However, these changes will be applicable for all patients. Single Protocol Linked (Sequential) Protocol Otometrics - ICS Chartr EP 200...
  • Page 38 F5 Trial Settings B. Click Rename Current C. Click D. Change Trial Settings Name. E. Click . The protocol will be listed in the left top panel on the Trial Settings window. Otometrics - ICS Chartr EP 200...
  • Page 39 Click to split the waveforms such that waveforms with the left ear stimulated are on the left side and waveforms with the right ear stimulated are on the right side. Grid Click to show horizontal and vertical grid lines. Otometrics - ICS Chartr EP 200...
  • Page 40 A. Click to begin data collection. Select the New Test tab. (A). Select a protocol (B). Select data collection options (C). Main Window, New Test Tab B. Go to 4.8Step 19 Monitor Data Collection ► Otometrics - ICS Chartr EP 200...
  • Page 41 Monitor Data Collection Step 19 A. Monitor data collection. Cursor B (A). Waveform Information Line (B). Waveform Bank Buttons (C) Waveform page number (D); max- imum 20 waveforms per page. Waveform (E) Waveform Work Area Otometrics - ICS Chartr EP 200...
  • Page 42 F8 Normative Data F12 Pause/Resume See normative data graphs Pause the current trial. for selected waveform. To Resume current trial. select all waveforms, click Ctrl+ A. C. Go to 5.1Step 20 EP Review Tab ► Otometrics - ICS Chartr EP 200...

  • Page 43: Review Collected Data

    The second number represents the channel. So, 5.1 is the fifth waveform for the left ear and 5.2 is the fifth waveform for the Review Tab - EP right ear. D. Go to 5.3Step 22 Work with Waveforms ► Otometrics - ICS Chartr EP 200...
  • Page 44 2. Select a test to see the corresponding trial setting details in the Calculation Box (E) on the Main Window. Review Tab - ASSR ► C. Go to 5.3Step 22 Work with Waveforms Otometrics - ICS Chartr EP 200...
  • Page 45 Select one or more waveforms (press and hold then click on each desired waveform). – Place the cursor over the waveform work area and right-click the mouse button to display the waveform pop-up menu. Otometrics - ICS Chartr EP 200...
  • Page 46 Copy the selected waveforms to the clipboard. Paste Insert waveforms from the clipboard. Delete Remove selected waveforms. Markers Add the selected marker at the site of the active cursor. Clear Markers Remove all markers on selected waveform(s). Otometrics - ICS Chartr EP 200...
  • Page 47 B. Select the marked waveform(s) and click to display the dialog box. Note Click an option (A) to • view the corresponding data graph. Normative Data Dialog Box C. Click to close the dialog box. Otometrics - ICS Chartr EP 200...
  • Page 48 B. Select the marked waveform(s), then select to display the dialog box. Note Click on a frequency • (A) to view the cor- responding data graph. Tone-Burst Normative Data Dialog C. Click to close the dialog. Otometrics - ICS Chartr EP 200...
  • Page 49 Threshold Table (C) tab to see a list of threshold channel parameters. Tone Burst Wave V Thresholds PediGram Tab B. Click to close the dialog box. C. Go to 5.4Step 23 View Data Graphs ► Otometrics - ICS Chartr EP 200...

  • Page 50: Print A Patient Report

    Macros can be edited and/or expanded upon once entered into the report. Set up a Macro A. Click F6 Report Tools B. Click on (in the menu bar). Otometrics - ICS Chartr EP 200...
  • Page 51 B. Place cursor in the report where you want the macro to be placed. Tools C. Click on (in the menu bar). D. Click Get Macro Get Macro Dialog Box E. Select the macro from drop down (A). Insert Click Otometrics - ICS Chartr EP 200...
  • Page 52 3. Select to include one or more of these options (C). Preview Click to view an online copy of the report. Print Report Dialog Box Print C. Click to send the report to the printer. Otometrics - ICS Chartr EP 200...
  • Page 53 5. Select to include the ASSR symbol legend in the report (E). Preview Click to view an online copy of the report. Print Report Dialog Box Print C. Click to send the report to the printer. Otometrics - ICS Chartr EP 200...
  • Page 54 Numbers (up to 5) – number Email – address 2. Click Add Referring Physician Dialog Box C. Click to create a new referring physician record. D. Go to 2.5Step 5 Select Referring Physician and Facility ► Otometrics - ICS Chartr EP 200...
  • Page 55 – Telephone – Number Contact person – 2. Click Add Referring Facility Dialog Box C. Click to create a new referring facility record. D. Go to 2.5Step 5 Select Referring Physician and Facility ► Otometrics - ICS Chartr EP 200...

  • Page 56: Maintenance And Troubleshooting

    Maintenance and Troubleshooting The troubleshooting information in this section includes: • Test Fixture A method for testing the status of the auditory stimulus and the data collection portions of the ICS Chartr EP 200 hard- ware. • Cleaning and Maintenance •...
  • Page 57 Plug the Test Fixture into the electrode jacks of the preamp and the transducer connector. Plug Test Fixture into Preamp Operator Login B. Turn on the PC and double-click (ICS Chartr EP 200 icon) to display the window. C. Select an Operator and click to display the Main Window.
  • Page 58 D, and click to delete the record. H. Return the equipment to operating status by closing ICS Chartr EP 200 and turning off the PC. Unplug the test fixture from the Preamp and reconnect electrodes, earphones, and bone oscillator.
  • Page 59 7 Maintenance and Troubleshooting Cleaning and Maintenance ICS Chartr EP 200 equipment does not require preventive maintenance. However, observe the following recommended guidelines. Keep the instrument clean and as free of dust as possible. Remove dust using a soft cloth or brush.
  • Page 60 Taskbar and select to display this prompt. C. Click to repair the database. D. Double-click (ICS Chartr EP 200 icon) to restart the application. If database problems continue, contact Oto- metrics Customer Support. Otometrics - ICS Chartr EP 200...

  • Page 61: Safety

    This Installation and Startup Guide contains information and warnings, which must be followed to ensure the safe per- formance of ICS Chartr EP 200 Local government rules and regulations, if applicable, should also be followed at all times. Symbols Used...
  • Page 62 Back Panel of the Chartr EP 200 when operating the device. Equipment Note 1: There are no user-serviceable parts inside the ICS Chartr EP 200 box. For the sake of safety, and in order not to void the Otometrics - ICS Chartr EP 200...
  • Page 63 Note 4: Unwanted noise may occur if ICS Chartr EP 200 is exposed to a strong radio field. Such noise may interfere with the process of recording correct measurements. Many types of electrical devices, e.g., mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of ICS Chartr EP 200 is restricted as much as possible.
  • Page 64 Note 20: Do not connect the ICS Chartr EP 200 (USB) system directly to the wall outlet. By not using the isolation station, you put the patient at risk to be exposed to power surges or electrical shock.
  • Page 65 The equipment is used in accordance with the instructions for use. The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. Otometrics - ICS Chartr EP 200...

  • Page 66: Technical Specifications

    9 Technical specifications Technical specifications ICS Chartr EP 200 System Safety The ICS Chartr EP 200 system, including the laptop and printer, is designed to meet medical power isolation standards and other applicable medical standards. Interface USB to PC Type Identification Chartr EP 200 is Type 1073 from Natus Medical Denmark ApS...
  • Page 67 115/230 VAC – 50/60 Hz Input Current: 2.70/1.35 A Leakage Current: < 100 µA Output Voltage: 115/230 VAC – 50/60 Hz Output Current: 2.60/1.30 A Operating Mode Warm-up time: <2 min Mode of operation: Continuous Otometrics - ICS Chartr EP 200...
  • Page 68 Safety: Chartr EP 200: IEC 60601-1, Class I, Type BF, IPXO: UL2601 Power Supply: IEC 60601-1, Class I, IPXO System: IEC 60601-1-1 EMC: IEC 60601-1-2 Test signal: IEC 60645-1/ANSI S3.6, IEC 60645-3, IEC 60645-7 Otometrics - ICS Chartr EP 200...
  • Page 69 Test protocols included for sleeping and awake patients. Protocols can be cre- ated and customized. System Capabilities Performance characteristics Analysis time: 5.0 – 9000 msec A/D resolution: 16-bit Artifact rejection: 100% full scale Points per trace: Otometrics - ICS Chartr EP 200...
  • Page 70 Parameters for tonal stimuli: Programmable – frequency, intensity, rise/fall time, plateau duration, envelope shape Rate: 0.2 to 180/sec Intensity: 0 dB to + 132 dB SPL Masking: White noise Transducers: TDH-49 earphones, insert earphones, bone conduction transducer Otometrics - ICS Chartr EP 200...
  • Page 71 Adult foam eartip, 13 mm – 80A4820900 Adult jumbo foam eartip, 18 mm – 80A4821100 Pediatric foam eartip, 10 mm – 80A4821000 ICS Chartr EP 200, VEMP Starter Kit Differential disposable electrodes – 8-64-21600 Otometrics - ICS Chartr EP 200...
  • Page 72 7-08-07500 Power cord, UK (straight) 7-08-07501 Power cord, US (straight) 7-08-07502 Power cord, AUS (straight) 7-08-07503 CD Mains Cord HO5VV, CHI 7-08-07504 Power cable, standard w/ "Schuko" plug 8-71-240 Power cord, DK w/plug 8-71-290 Otometrics - ICS Chartr EP 200...
  • Page 73 Power cord, CHI w/plug 8-71-86400 Mains Adaptor Cables, EU 7-08-10500 Mains Adaptor Cables, UK 7-08-10501 Mains Adaptor Cables, US 7-08-10502 Mains Adaptor Cables, AUS/CHI 7-08-10503 Mains Adaptor Cables, SWISS 7-08-10505 Mains Adaptor Cables, DK 7-08-10506 Otometrics - ICS Chartr EP 200...
  • Page 74 Guidance and manufacturer’s declaration tables • ICS Chartr EP 200 is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely.
  • Page 75 Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems ICS Chartr EP 200 is intended for use in the electromagnetic environment specified below. The user of ICS Chartr EP 200 should ensure that it is used in such an environment.
  • Page 76 RF transmitters, an electromagnetic site survey should be con- sidered. If the measured field strength in the location in which ICS Chartr EP 200 is used exceeds the applicable RF com- pliance level above, the ICS Chartr EP 200 should be observed to verify normal operation. If abnormal performance is observed, additional measures might be necessary, such as reorienting or relocating ICS Chartr EP 200.
  • Page 77 ICS Chartr EP 200 The ICS Chartr EP 200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ICS Chartr EP 200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip- ment (transmitters) and the ICS Chartr EP 200 as recommended below, according to the maximum output power of the communications equipment.

  • Page 78: Installation Reference

    10 Installation Reference Installation Reference The Installation Reference section provides information needed during set up of the ICS Chartr EP 200 equipment. It includes the following topics: • Set up the Hardware • Software Overview • Set up the Test Site Facility Information •...
  • Page 79 Functional Earth Connection symbol), using a 3 mm Hex wrench. When ICS Chartr EP 200 program starts for the first time, a Workstation name dialog box displays. Type a unique name that will identify the workstation and click...
  • Page 80 Use fiber-optic network connections to install data acquisition workstations on a network. This will preserve the patient's electrical isolation. 10.2 Software Overview ICS Chartr EP 200 is an easy-to-use auditory evoked potential (EP) system that operates in a Windows operating system environment. Use a mouse or keyboard to communicate with the software. •...
  • Page 81 The thresholds are established by conducting a series of tests on normal hearing adults using facility equip- ment. Use this procedure to enter the facility threshold values in ICS Chartr EP 200. Once the biological calibration (i.e., listening check) is performed and correction value is determined, then changes can be made in the Threshold Adjustments table.
  • Page 82 1. Select a transducer from the list (A). 2. Type the dB HL values for each tone burst (B). Click 3. Type the value (C). Threshold Adjustments Dialog Box C. Click to save the new values. Otometrics - ICS Chartr EP 200...

  • Page 83: Diagnostic Calibrations

    11.1 Calibrate Hardware after Installation All ICS Chartr EP 200 systems are calibrated at Otometrics prior to shipment. However, Normal Hearing Level Thresholds (dB nHL) can be modified as part of the system setup. After the initial installation and calibration, hardware components should be calibrated annually and as needed when sys- ICS Chartr EP 200 User Manual tem components are replaced or if the operating environment changes.
  • Page 84 X in the Calibrated column. Frequency-Specific Tone Calibration Dialog Box G. Repeat step for each frequency you want to calibrate. H. Repeat steps for each transducer used at your facility. Click to close the dialog. Otometrics - ICS Chartr EP 200...
  • Page 85 Step 3asdfg sdg Step 4sdf gsd Step 5fg sdfg Step 6sdg Step 7sdfg Step 8sdfg Step 9sdfg Step 10sdfg Step 11sdfg Step 12sdfg Step 13sdfg Step 14sdfg Step 15sdfg Step 16sdf Step 17g sdf Otometrics - ICS Chartr EP 200...
  • Page 86 Step 18g sd Step 19fga Step 20sdf a Step 21sdf Step 22asdf Step 23asd Step 24f asd Step 25sfg sdfgg Step 26sdfg sdfg Step 27sd fg Step 28s dfg Step 29sd fgsdfg Step 30sdfg sdg Otometrics - ICS Chartr EP 200...

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