otometrics ICS Chartr EP 200 Installation manual

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

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.
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Table of Contents
1 Introduction 5
2 Prepare System for Data Collection 6
3 Prepare Patient for Testing 12
4 Collect Patient Data 34
5 Review Collected Data 43
6 Print a Patient Report 50
7 Maintenance and Troubleshooting 56
8 Safety 61
9 Technical specifications 66
10 Installation Reference 78
11 Diagnostic Calibrations 83
3
User Guide
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1 Introduction
The ICS Chartr EP 200 Installation and Startup Guide is intended for users of the system. It begins with step-by-step instruc-
tions for setting up records, preparing the patient, collecting data using the Otometrics-supplied default settings, reviewing
data, and preparing reports. The Installation Reference section provides information on setting up the hardware followed
by instructions for performing the installation calibration requirements. The Guide is organized as follows:
• Prepare System for Data Collection
• Prepare Patient for Testing
• Collect Patient Data
• Review Collected Data
• Print Patient Report
• Maintenance and Troubleshooting
• Safety
• Technical Specifications
• 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.
1.1 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.
The ICS Chartr EP 200 system can be configured for a wide variety of electrophysiological tests, and it can be programmed
for single protocol or linked protocol operation. The user can select or change the default parameters for a particular test.
The VEMP monitor is used to provide biofeedback by monitoringthe state of a muscle during Vestibular Evoked Myogenic
Potential testing using surface electromyography.
1.2 Intended Use
The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and
lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential test-
ing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel
with prior knowledge of the medical and scientific facts underlying the procedure.
Caution •Federal Law restricts this device to sale by or on the order of a licensed physician.
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1 Introduction

1.3 Intended User
This manual describes the use of the device in combination with the software. Readers are assumed to have prior know-
ledge of the medical and scientific facts underlying the procedure. 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.
1.4 Other Resources
This Installation and Startup Guide is an introduction to ICS Chartr EP 200. For more information, please refer to the fol-
lowing.
1.4.1 ICS Chartr EP 200 User Manual
The ICS Chartr EP 200 User Manual provides information on all aspects of the ICS Chartr EP 200 system including:
• Functional description of each window and dialog box
• Advanced Procedures
• Data Collection and Analysis
• Archiving Options
• Customizing Reports
• Troubleshooting
Note •The User Manual can be accessed through Help in the software.
1.4.2 Otometrics Customer Support
Otometrics Customer Support is available at www.natus.com or contact your local distributor.
2 Prepare System for Data Collection
2.1 Step 1 System Startup and Operator Login
A. Press the Power button on the EP PC and wait for the Windows® Desktop to display.
B. Double-click (ICS Chartr EP 200 icon) to display the Operator Login dialog box.
Alternate: Click Start on the Taskbar and select Programs> Otometrics > ICS ChartrEP.
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C. Select an operator from the list.
Operator Login Dialog Box
1. Click on your name.
2. Click OK to display the ICS Chartr EP 200 Main
Window.
If your name is not on the list, click New to display the
Add Operator dialog box. Go to 2.2Step 2 Add an
Operator ►7.
D. Go to Step 3 Study Main Window ►8.
2.2 Step 2 Add an Operator
A. Type the requested information.
Add Operator Dialog Box
1. Type your last name and degree; type your first
name. [required]
2. Type your address:
–Street
–City
–State
–Zip Code
–Phone Number
–Identification (i.e., a work ID)
3. Click OK.
B. Click OK 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 ►8.
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2.3 Step 3 Study Main Window
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
patient selected
Function/Purpose
ATitle bar View patient and operator names
BMenu bar Select program options
CToolbar Quick access and labeling waveforms
DOngoing EEG box Display EEG waveforms during data collection
ETabs - Review, New Test, and Settings Select a tab to review data, select a protocol, or change protocol set-
tings
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Additional areas displayed with
patient selected
Function/Purpose
FTest Lists - New or Review Depending on tab selected, displays test procedures available (New
Test tab) or performed (Review tab).
GCalculation box View waveform calculations
HFunction/Operation keys Select program options
IStatus bar View program information
JWaveform data Displays the number of accepted sweeps and the number of rejected
sweeps during collection. Displays Cursor A location (ms), Cursor B loc-
ation (ms), the difference between Cursor A and B latency (A – B), the
difference between Cursor A and B amplitude (Av – Bv), the EMG value
(VEMP only), the Interaural Wave V (IT5), and the Asymmetry Ratio
(VEMP only).
VEMP monitoring is available only if the VEMP monitor application has
been included.
KWaveform work area View collected waveforms
LX-axis labels (area indicated by gray
rectangle)
When waveforms with the same sweep time and delay are displayed,
the X-axis divisions are labeled in ms
MWaveform bank numbers Select waveform by number
NWaveform page comments box Type comments to be saved with waveforms
B. Click F1 Help for additional information.
C. Go to 2.4Step 4 Set up Patient Record ►10.
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2.4 Step 4 Set up Patient Record
A. Click F2 New Patient on the Main Window to display the Add Patient Information dialog box.
B. Type/select the requested patient information.
Add Patient Information Dialog Box
1. Type this information:
–Name (Last,First [required]
–Birthdate[required]
–Address ,City,State,Zip Code
–Phone Number
–Identification (i.e., a work ID)
2. Select the Gender [required].
C. Click OK to create a patient record.
D. Go to 2.5Step 5 Select Referring Physician and Facility ►11.
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2.5 Step 5 Select Referring Physician and Facility
A. Click the Physician Order tab.
B. Select the Referring Physician and Referring Facility
Edit Patient Information Dialog Box
1. Click the Physician Order tab
2. Click on the Referring Phys-
ician's name.
Note •If the Referring Phys-
ician is not on the list, go to
6.5Step 28 Set up Referring
Physician Records ►54.
3. Click on the Referring Facility's
name.
Note •If the Referring Facility
is not on the list, click None
Selected or go to 6.6Step 29
Set up New Referring Facility
►55.
4. Click OK.
C. Click OK to save the information on both tabs.
D. Go to 3.1Step 6 Patient Preparation ►12.
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3 Prepare Patient for Testing
3.1 Step 6 Patient Preparation
Before preparing the patient, turn on the Chartr EP 200 unit and launch the ICS Chartr EP 200 software.
EP tests are best performed on a patient who is quiet, comfortable, and cooperative. If the patient is active, the test time
may be longer and the test results may be compromised by a high level of noise (acoustic or myogenic) during the record-
ing.
3.1.1 Supplies Required
The following supplies should be available in the test area:
• NuPrepTM electrode prep, or other skin prep materials.
• Gauze pads or cotton swabs for application of skin prep.
• Electrodes (non-disposable or disposable)
Braid or tape electrodes together to reduce noise and for better performance.
– Use non-disposable electrodes of the same metal type (i.e., silver, gold, etc.).
– Non-disposable electrodes do not last forever. Replace the electrodes if noisy recording persists or impedances
are high.
– Clean and rid non-disposable electrodes of old paste.
– Check the expiration date if disposable electrodes do not adhere.
– Electrode jumper.
– Conductive paste for non-disposable electrodes.
– Cotton balls and/or tape for adhering the electrodes in place.
– Disposable insert earphone eartips for adults and pediatrics.
3.1.2 Test Room Setup
In order to obtain clean, accurate results, the patient should be comfortable. The patient should preferablybe lying supine
or reclined in a comfortable chair with head and leg support.
Try out the chair or table and lie there for awhile. Are you comfortable? Pillows and blankets should be available to ensure
patient comfort.
Instruct the patient to keep his/her eyes closed and relax. Let the patient know that sleeping is the optimalstate.
Turn off the lights to encourage relaxation. If the room has fluorescent lights, it is best if these are off as they emit noise. If
the lights are on a dimmer switch, make sure the switch is not in a mid position as this can cause noise.
Position the patient away from any devices or sources that cause electrical artifact (i.e., computer monitors).Make sure all
cell phones and pagers are off (not just silenced) during data collection.
3.1.3 Skin Preparation
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
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that large, so it is more efficient to accurately scrub the small area where the electrode will be placed than to scrub
haphazardly on a large surface area.
• If using non-disposable electrodes, fill the cup of the electrode with a pea-sized amount of conductive paste. Place the
electrode on the prepared site and then secure it with a little cotton or tape. When using a Cz placement, it is best to
use non-disposable electrodes. If the patient has a lot of hair product, place an alcohol pad at the electrode site for a
minute to dissolve the hair product.
• If using disposable electrodes, it is best to use a dry prep. The use of alcohol can dry out the skin too much and cause
the electrode not to adhere. If using a wet prep, wipe the skin clean of excess moisture before placing the disposable
electrode.
Go to 3.2 Step 7 Apply Electrodes ►14 for information on electrode montages.
3.1.4 Cleaning Non-Disposable Electrodes
Use clean electrodes. Electrodes that are not properly cared for will result in noisy, inaccurate data, and high impedances,
and can also cause trending in the waveform (the rising or falling of the waveform away from the baseline).
• To clean paste off of the electrodes, use a soft toothbrush (i.e., infant toothbrush) and some warm water. Do not leave
electrodes soaking in water for hours. Handle the electrode wires with care as not to break them.
• If using silver chloride, verify that the chloride has not chipped off. To re-chloride the electrodes, place only the cup of
the electrode into a small amount of chlorine bleach. Soak electrodes for only 20 minutes. Do not let the wires touch
the chlorine bleach.
3.1.5 Listening Check
Perform listening checks routinely to ensure that the equipment is functioning properly.
• Using a person who has auditory thresholds below 10 dB, make sure they can hear a very faint sound for each stimulus
type, and transducer at 0 to 5 dB.
• If the person cannot hear the stimuli, contact the manufacturer or your local representative to troubleshoot your unit.
• See Establish Normal Hearing Level Thresholds ►81.
3.1.6 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. The shoulder harness is used to
drape the preamp over the patient’s shoulder or over the back of the patient’s chair/recliner.
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3.2 Step 7 Apply Electrodes
Apply the electrodes to the patient. Use an appropriate electrode/transducer combination for the data being collected
and the patient's status. The system applies labels to collected waveforms based on the stimulated ear.
3.2.1 Electrode Montages
Below are proper connection of electrode wires into the Chartr EP 200 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.
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3.2.2 1-Channel Recordings
Please note that 1-Channel recordings should only have 3 electrodes connected to the patient preamplifier (Ch 1 ACT, Ch
1 REF, and GND - ground). Channel 2 electrode jacks are not used. Jumpers should not be connected. Leaving a jumper or
electrode lead connected can result in inaccurate data and may introduce noise into the recording.
AUDITORY BRAINSTEM RESPONSE MONTAGES
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.
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3.2.3 Tips for TM (tympanic membrane) ECochGtrode
Always perform an otoscopic inspection before placing the TM electrode. Make sure that the ear canal is clear of ceru-
men. Do NOT place the TM electrode if the patient has a tympanic membrane perforation. To assist in reducing imped-
ance, place 2cc of saline into the ear canal and then drain the ear. Do NOT place saline in the ear if planning to perform
VNG/ENG calorics on the same day.
Instruct the patient that a small flexible tube will be inserted into the ear. The patient may feel a little pressure and may
hear a "thud" when the end of the electrode touches the tympanic membrane.
Place a very small amount of conductive gel over the hydrogel end of the TM ECochGtrode making it slick and less sticky.
Too much conductive gel can plug the insert or make removal difficult.
The ear canal should be in direct light when placing the electrode. Using a microscope or headlamp is appropriate.
After the TM ECochGtrode is in place, secure the cable to the patient so that the weight of the cable does not pull the
electrode out of the ear.
Insert the foam eartip into the ear and on top of the TM ECochGtrode tubing. Hold the tubing of the TM ECochGtrode
when inserting the foam eartip so that the electrode is not pushed against the patient's tympanic membrane.
Electrode impedance will be very high for the TM ECochGtrode (>20 K Ohms) and will result in a large inter-electrode
impedance difference. Because the TM ECochGtrode is closer to the neural generation source, the inter-electrode imped-
ance is less of a problem. Verify that artifact rejection is OFF.
After data collection, remove the foam eartip, then the TM ECochGtrode. Inspect the ear canal and the tympanic mem-
brane. 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.
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3.2.4 Tips for Tiptrodes
The Tiptrode consists of two components: the eartip/electrode and the connector/cable assembly. The electrode is the
foam eartip wrapped with gold foil. The connector/cable has an insulated alligator clip for attaching the eartip/electrode to
the tubing for transmitting auditory stimuli and an insulated wire to conduct the electrode signal.
Attach the eartip/electrode to the connector. Squeeze the metal clip open and then slide the eartip/electrode on making
sure that the alligator clip is touching the gold foil.
Connect the tubing to the output of the insert earphone.
Remove the tubing that is currently on the insert earphone and replace it with the tubing on the Tiptrode.Do NOT
double the length of the tubing by attaching the two sets together.
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 •See ►20 for continuation of this electrode placement.
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