User Guide Essentia EEG System

Essentia User Guide 100870-639 Rev 07
© 2021 Cadwell Industries, Inc. 1

Copyright and Disclaimer Information

© 2021 Cadwell Industries, Inc. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system,
translated into any language or computer language, in any form, by any means, electronic, mechanical,
optical, chemical, manual, or otherwise without prior written consent of Cadwell Industries, Inc.
Disclaimer
Clinical conclusions and decisions based on the use of this product are the responsibility of the user. Cad-
well does not accept any liability or responsibility for damages arising out of the use of or inability to use
this product. This manual provides an operational summary for the Essentia system. It does not provide
clinical training. It is assumed that the user has adequate clinical training to perform neurodiagnostic
procedures.
This document may contain technical inaccuracies or typographical errors. Changes are periodically
made to the information herein; these changes will be incorporated into future revisions of this doc-
ument. Features and specifications are subject to change without notice.
Cadwell does not accept any liability for the use or misuse, direct or indirect, of this product. Users must
accept all responsibility for any results obtained by or concluded from data obtained by the products.
The user must accept all responsibility for results obtained by software from Cadwell Industries, Inc.
Cadwell also expressly disclaims all liability for direct, indirect, special, incidental or consequential dam-
ages, including but not limited to, damage or loss of property or equipment, loss of profits or revenue,
cost of purchase or replacement of goods, or claims of customers that result from the use of the Arc
Software. In no event shall the liability of Cadwell, whether in tort, contract or otherwise, exceed the
cost of the parts or products. However, you may have legal rights which vary from state to state.
Trademark Notices
Cadwell, Arc Essentia, Arc Alterna, CadLink, Q-Video, and Easy are registered trademarks and Arc Apol-
lo+, Arc Apollo Plus, CadCapture, CadSchedule, StimTroller, Synopsis, Zenith, and Zenect are trademarks
of Cadwell Industries, Inc. The absence of a product or service name or logo from this list does not con-
stitute a waiver of Cadwell’s trademark or other intellectual property rights concerning that name or
logo. Other brand and product names are trademarks or registered trademarks of their respective hold-
ers.
Cadwell Industries, Inc. reserves the right to modify, delete, extend, or improve features described
herein without notice.
Patents
www.cadwell.com/patents


Table of Contents
Copyright and Disclaimer Information 2
Disclaimer 2
Trademark Notices 2
Patents 2
Table of Contents 4
Intent, Overview, Indications for Use 6
User Guide Intent Statement 6
References 6
Arc 6
CadLink 6
EEG Hardware 6
General 6
Overview 6
Essentia Indications for Use 7
Arc Essentia Setup Instructions 8
Arc Essentia Amplifier Options 9
E1A for Private Practice 9
E3A for Brain Health Monitoring in the ICU and Long-Term Monitoring (LTM) 9
Connections and Power Instructions 10
Computer, Network, IT Security 11
Computer Requirements 11
PC Purchased from Cadwell 11
Computer Peripherals 11
Configuration of Non-Cadwell Supplied Computers 11
Arc Reference Documents 11
Network and Storage Requirements 11
Antivirus Software and Disk Encryption Software Applications 12
Authorized User Access 12
Essentia Cybersecurity 12
Arc Application Instructions 13
Opening and Closing Arc Software 13
To Open the Arc program 13
To Close the Arc program 13
Subsequent operation after interruption and recovery of power lasting 30 seconds or more: 13
Essentia Setup Verification 14
Starting a New Recording 14
Reviewing the Recording 16
Additional Help Resources 17
Generating Reports 18
Narrative Resolver 18
Report Generation Controls 20
Release Note Reference 21
General Warnings and Cautions 22
Symbols and Meanings 25

Date of Manufacture 27
Year and Month of Manufacture 27
Essentia Essential Performance 28
SpO2 Essential Performance 28
Maintenance Information 29
Factory Calibration 29
Essentia Specifications and Operating Environment and Limits 29
Regulatory Classification Information 29
Type of Protection against Electric Shock 29
Degree of Protection against Electric Shock 29
Mode of Operation 30
Safety 31
Essentia Electromagnetic Emission and Immunity to Electromagnetic Disturbances 34
Essentia Cleaning Instructions 38
Disposal of Equipment 39
Warranty Information 39
Electrode Catalog and eStore 39
Customer Support and Contact Information 40
US Customers 40
Service Support 40
Application Support 40
International Customers 40
EU Importer 40
Remote Assistance 40

Intent, Overview, Indications for Use

User Guide Intent Statement
This device is intended for qualified users only. Refer to your institution’s policy regarding particular
training and qualifications required to operate this equipment.
This manual is a basic guide to installing and operating your Cadwell system. Please refer to the fol-
lowing information sources for more detail on operating and servicing your product.
References
Arc
Arc Help File
369045-934 Arc Installation Instructions
369045-810 Arc Software Release Notes
100870-623 Arc System Configuration Document
369045-623 Installation Instructions for Arc Language Files
CadLink
369044-620 CadLink User Manual
369044-623 CadLink HL7 Interface Manual
369044-624 CadLink System Configuration
369044-625 CadSchedule User Manual
EEG Hardware
100870-931 Arc Essentia Spec Sheet
General
308014-000 Minimum Computer Specifications
Cadwell on the Web: www.cadwell.com
Overview
The Essentia can be configured in a portable laptop computer, tablet, or desktop PC version. Laptops,
tablets, mini-towers, LCD monitors and all-in-one PCs are available from Cadwell.
Two versions of the Arc Essentia are available. The Essentia E1A is designed for simple EEGs in a private
practice setting. The Essentia E3A is intended for long-term monitoring (LTM) and epilepsy monitoring
(EMU), and for brain monitoring in Intensive Care Units (ICU). The Essentia E1A and E3A have an LED top
panel on the amplifier to allow for impedance checking, electrode continuity check and to continue
recording. See the Essentia Amplifier Configurations section below for more details. All versions come
equipped with a photic to perform activation procedures.

Essentia Indications for Use

Cadwell Flex Indications for Use (Arc Alterna, Arc Essentia):
The Cadwell Flex system is indicated for prescription use to acquire, record, transmit and display
physiological and environmental data for electroencephalographic (EEG) ambulatory and/ or clinical
studies of patients of all ages.

Arc Essentia Setup Instructions
Unpacking the System
Thank you for selecting the Cadwell Arc Essentia system! It’s time to unpack the contents of your sys-
tem. As you unpack, please carefully check to make sure the contents of the shipping box match the
packing slip.
NOTE: DO NOT discard any boxes or packing material until you can account for all items on the packing
list.
You should receive the following as standard items:
1. Arc Essentia Amplifier (E1A or E3A)

2. 6' USB-A to USB-B 2.0 Cable
NOTE: If you purchased your computer from Cadwell, all necessary Windows® and Arc software are pre-
installed on your computer. There is no need for you to install any software. Please store media that
shipped with your system in a secure location. These were included as a back-up copy only. Laptop com-
puters may require you to make backup CDs for the computer.
NOTE: If a computer is purchased from a source other than Cadwell, the Windows Operating System
must be properly configured, Arc Software must be installed and the software license activated. Refer to
the Configuration of Non-Cadwell Supplied Computers sections below for detailed instructions.
Please check for any optional items you may have ordered. These may include, but are not limited, to
the following:
Optional Accessories for Essentia EEG Systems

Item Part Number Item Part Number
Arc Photic Stimulator 190298-200 Remote Input Box 190294-200
10' USB 3.0 for Photic 286129-200 25' Remote Input Box Cable 199283-000-025
25' USB 3.0 for Photic 286130-200 Nonin USB Oximeter 198232-200
Disposable EEG Electrodes* 302642-000 Persyst Software* 295044-000
Gold Cup EEG Electrodes* 202110-000 Patient Event Switch 199244-200-XXX
Logitech USB Camera 198233-000 Rolling Stand 198186-000
PTZ IP Camera 198273-000 Articulating Arm for Photic* 197260-200
Fuzion Cart* 111223-000 Articulating Arm for Essentia* 197264-200
EEG Cart 112001-200
* Contact Sales Support for additional options

Arc Essentia Amplifier Options

The Arc Essentia offers the following two distinct levels of performance.
E1A for Private Practice
The E1A option provided storage rates of 250 and 500 Hz, electrode continuity check, and accom-
modates EEG studies in a private practice setting. The E1A has black protective bumpers. The Essentia
E1A has an LED top panel on the amplifier to allow for impedance checking, electrode continuity check
and to continue recording.
E3A for Brain Health Monitoring in the ICU and Long-Term Monitoring (LTM)
The E3A option provides storage rates of 1000 Hz and 2000 Hz for continuous EEG monitoring in the ICU
and LTM. Additional features not provided in the E1A version include USB SpO2 (contact Cadwell for
device availability) and continuous impedance capabilities. The E3A has orange protective bumpers. The
Essentia E3A has an LED top panel on the amplifier to allow for impedance checking, electrode con-
tinuity check and to continue recording.

Connections and Power Instructions

To turn the equipment on:
1. Power on the computer and monitor.

2. Connect the Essentia amplifier to a USB port on the computer.
3. Connect the photic to a USB port on the computer.
4. If patient event button purchased, plug into side input on the Essentia amplifier.
5. If USB Oximeter (SpO2) purchased, plug into the USB port on the computer.
To turn the equipment off:
Turn off equipment in the following order:

1. Close the Arc Essentia program and any other related programs running on the computer.
2. Shut down Windows.
3. Turn off monitor (for desktop configurations only).
Connecting USB Pulse Oximeter and Probe Sensor:
1. Connect the USB Oximeter 3012LP to the acquisition PC USB port.

2. Insert the patient's finger/toe into the sensor and ensure the patient’s digit reaches the end of the
sensor.
3. Direct the cable along the patient’s finger/toe, parallel to the arm/leg.
4. Connect the sensor cable to the USB Oximeter 3012LP.
5. Both heart rate and oxygen saturation values will be displayed on the EEG recording screen.
NOTE: Refer to the Operator’s Manual for more detailed technical information.

Computer, Network, IT Security

Computer Requirements
A PC is required for use to run the Arc software. Either a laptop, tablet or desktop PC may be used. The
PC may be purchased from Cadwell and provided with the Essentia system, or the customer may pur-
chase their own PC as long as it meets the minimum computer requirements specified by Cadwell.
Refer to the Minimum Computer Specifications document (PN 308014-000) for current requirements.
NOTE: Installing Arc software on operating systems and computers that are not recommended
by Cadwell is not only considered unsafe, but will be unsupported by Cadwell and may void any
equipment or software warranty.
PC Purchased from Cadwell

NOTE: If you purchased your computer from Cadwell, all necessary Windows® and Arc software
are pre-installed on your computer. There is no need for you to install any software. Please
store media that shipped with your system in a secure location. These were included as a back-
up copy only.
Computer Peripherals
Cadwell also makes available accessories and PC-related interface and peripheral devices such as an
external keyboard, mouse, speaker, printer, camera, and interconnection cables for the customer as
desired.
Configuration of Non-Cadwell Supplied Computers
NOTE: If a computer is purchased from a source other than Cadwell, the Windows Operating Sys-
tem must be properly configured, and Arc Software must be installed and activated.
Arc Reference Documents

The reference document 369045-934 Arc Installation Instructions will be provided with the system or on
the Arc media in the Documents folder. Follow the instructions to configure the computer for use with
Arc software.
The 100870-623 Arc System Configuration Document contains additional related details.
Network and Storage Requirements

Cadwell recommends a gigabit connection where available. At a minimum, CadLink Server requires 8
Mbps bandwidth per client for data and database synchronization. Speeds below this level may cause
degraded performance and/ or unstable synchronization. Depending on the number of clients, number
of channels, sampling rate, video quality, a much higher bandwidth may be required.

Cadwell applications using CadLink Server can be successfully configured in a multi-hospital setting.
CadLink is designed to allow users to review data from home, office, lab, or anywhere an internet con-
nection can be made. It is important that your configuration suits your networking infrastructure. The
two important connections are the network between the user systems accessing the data and the
CadLink Server, and between the CadLink Server and the data storage location. If the data folders are
using a network location, then the CadLink Server service needs to run under an account that has access
to those locations.
See 369044-624 CadLink System Configuration for more information.
Antivirus Software and Disk Encryption Software Applications

Cadwell encourages all customers to take necessary precautions to protect computer systems from mali-
cious programs. We also want you to protect the privacy of your patient data. Though Cadwell has con-
figured Arc software with multiple AV and disk encryption applications, we cannot verify compatibility
with all applications available in the marketplace.
Authorized User Access

CadLink users must be created within the Arc application in order to allow access. Optionally, an Active
Directory User Group can be added and configured within CadLink to allow authorized access to a group
of users. Unauthorized access is prevented by ensuring that Arc software access requires valid cre-
dentials.
It is necessary to run the software as intended.
Essentia Cybersecurity
To help address unwanted access or intrusions into Essentia, the following are highly recommended:
l The use of complex passwords.
l The use of anti-virus and anti-malware software.
l The use of firewalls.
In the event of a virus or malware alert and/ or unwanted access or intrusions into Essentia, the fol-
lowing are highly recommended:
l Physically disconnect the computer from the network.
l Unplug the computer, especially if unable to disconnect from the network.
l Contact IT department immediately.

Arc Application Instructions

Opening and Closing Arc Software
To Open the Arc program
1. Double-click on the Arc icon on the Windows desktop.
2. Log in to Arc with your Cadwell login.
NOTE: The default user name and password is “admin”.
It is recommended that the user change the admin password.
To Close the Arc program

Click on the red X in the upper right hand corner of the screen.
Subsequent operation after interruption and recovery of power lasting 30 seconds or more:
If the photic light was in use when the power outage occurred you will need to restart the sweep after
the system has regained power and Arc has relaunched and appended the interrupted study. If a pulse
oximeter is in use it will automatically acquire data once the system has regained power and Arc has
relaunched and appended the interrupted study. The Essentia amplifier will self-recover once power is
restored, all system settings will be the same as prior to the power failure.

Essentia Setup Verification

Starting a New Recording
1. Select the Record at the upper left.
2. Select an appointment from the Scheduled Appointments window or create a new one (auto-
selected when launched), then select the type of study that you would like to test from the but-
tons provided above the Scheduled Appointments window.
NOTE: If CadSchedule and/ or HL7 are not installed, the Scheduled Appointments section of the
window will not appear, click on the study type button to begin a recording.

3. You will see this screen as it loads:
4. Once the study is ready to begin, click the button at the upper left.

5. If a photic is connected to the system, select the photic icon from the top toolbar: Select
the Test button and verify that the photic flashes once.
6. Let the traces display and record for five minutes.

7. Click on the Patient Info tab on the upper left side of the screen to bring up the corresponding
window and enter additional information as necessary.
8. After the study has elapsed five minutes, click on the red X in the upper right-hand corner and
select Yes on the prompt that appears.
Reviewing the Recording

1. To review the recording that you just made, click on the Review Records tab next to Start Record-
ing toward the upper left.

2. Highlight the patient recording that needs to be reviewed and select the file open icon or double
click the patient entry to open the recording for review. To aid in more quickly locating the
desired patient, the header of each column is a search field. Type in the fields to dynamically filter
down the list to find the desired recording. Again, once the recording is highlighted, select the
open icon or double click and the trace window will display. The refresh icon at the bottom of the
panel allows the user to force a refresh of the review records list.
3. The record will open and review can begin. If video was recorded, click on the button to add a
video window to the view.
Additional Help Resources
Release notes (369045-810) can be found in the Documents folder on the software installation disc
(369045-200).
For more information on how to use the Arc software application and equipment, please refer to
the Arc Help Topics. Whenever the Arc application is open, select the question mark at the upper right,
then select Help to access the Help Topics.

Generating Reports
To generate a report in Arc, go to the Studies tab of the application and open a record for review. Select
the icon from the top toolbar, the Select Report window will appear. The user highlights the
report that they would like to generate on the open file and clicks on the Select key.
*note: CadReport allows users to customize their own reports with ease.
Narrative Resolver
l Check the box next to the paragraph that the user would like to have included in this particular
report.
l If there are selection lists associated with that paragraph, then the paragraph resolver will
appear. Mark the selections that apply.
l If the wrong selection was made in the paragraph resolver, then the user can select the Reset but-
ton and make selections again.
l If the user does not want to include any selections with the paragraph for that particular report,
then select Skip. This will remove the selection entirely from the paragraph.
l If multiple selection lists are associated with the selected paragraph, then the user can select
Next to advance to the next selection list in the paragraph.

The Narrative Resolver includes all narratives created for the selected report. The user can navigate
through the narratives and answer them in any order.
l Once the user has completed all paragraphs/ narratives that they would like included in the
report, they select OK.

l If some narratives have been skipped, then an unresolved narrative prompt will appear. Select
Yes if done or No to go back and resolve more items.

*note: As the narratives/ paragraphs are being selected the report will reflect the current selections.

Report Generation Controls

The following controls will show up on the right hand side of the generated report.
Help: This option opens the Help Files.
Insert My Signature: Select this option to insert the current logged in Arc user's signature. The signature
will insert at the current position of the cursor in the report. If there is not an associated signature for
that user a prompt will appear. To associate a signature, navigate to the users section in the Admin-
istration panel of Arc.
Insert Other Signature: Select this option to associate an Arc user's signature other than the user who is
currently logged in. When this option is selected, the below User Authentication window appears.
Select the User Name from the list and enter the password, select Authenticate. That authenticated Arc
user's signature will then be inserted at the current cursor position in the report.

Save as PDF: Check this box to have the generated report automatically save as PDF.
Save and Exit: Select this option to save the report and exit report generation. The report will be shown
in the associated documents list for the patient recording.
Exit without Saving: Select this option to exit the report generator without saving the currently gen-
erated report.
Release Note Reference

Release notes will be automatically installed during the installation of the Arc software, and may be
optionally viewed at the end of the installation. Alternatively, see the Arc Help file (click the in Arc).

General Warnings and Cautions

1. Federal law restricts sale of this system to, or on the order of, a physician.
2. No user serviceable parts inside. Service by Cadwell Industries, Inc. and other authorized bodies
only. Do not modify this equipment without authorization of the manufacturer.
3. High levels of static discharge can cause a momentary pause in data collection. A USB recon-
nection may be required to resume data collection on the PC.
4. Inspect all cables before and after each use. Discard cable if insulation is damaged or if the cable
or connectors are damaged in any manner.
5. Run system calibration to confirm amplifier is operational.
6. Cleaning instructions in this manual need to be strictly adhered to.
7. Do not attempt to use the system if it has been immersed in liquid. The system is not water res-
istant. The contact of liquids with the internal parts and connectors of the system should be
avoided at all times.
8. The user may have a mild reading vision impairment or vision corrected to log MAR 0.2 (6/10 or
20/32). The user may have one arm/ hand capable of holding mouse and placing electrodes. The
user can have hearing impaired by 40% resulting in 60% of normal hearing at 500 Hz to 2 kHz.
9. The patient is not the user of the device.
10. The use of electroencephalography equipment in conjunction with high-frequency surgical equip-
ment may result in burns at the EEG electrode placement sites and/ or damage to the EEG amp-
lifiers in the event of a defect in the neutral electrode connection of the high frequency surgical
device. Please refer to the high-frequency surgical equipment's user documentation for instruc-
tions for use.
11. Output of analyzers and detectors should not be solely relied on for review of a study. They are
tools used to assist a qualified practitioner with the analysis and diagnosis of the patient.
12. The system is not defibrillator proof. The system must be disconnected from the patient when a
defibrillator is used on the patient.
13. Patient shall not be exposed to more than 30 minutes of continuous photic stimulation at the
maximum stim rate, and the specified minimum distance of 18 cm.
14. The LEDs on the photic should not be looked directly into by production/ service technicians or
physicians/ medical techs.
15. Do not suspend the photic directly over the patient in case of mechanical failures. Do not place
the amplifier nor photic on the cart arm directly over the patient.
16. Incompatible components can result in degraded performance.
17. Only connect accessory items specified as part of the Medical Electrical (ME) system.
18. Type BF, IEC60601-1 Isolation
19. When using remote control, it is the responsibility of the end user to assume all risk and respons-
ibilities for patient care and the user should not solely depend on network connection for patient
care.
20. Caution must be taken when moving the cart with the arm as these arms can expand making the
cart too wide for some doorways. Before moving the cart, ensure that all arms are folded and all
elbows are tightened.
21. Periodically check the fasteners securing or photic to the cart arm.
22. Caution must be taken when swinging the arm. The arms have a tension spring which can result
in unanticipated expansion. Before expanding an arm, check the elbow for tension by turning the
knob. A clockwise turn tightens the locking mechanism, counterclockwise loosens the lock.

23. The intended user should be trained in the recognition of clinical ictal behavior and EEG pattern
recognition. The user should be able to recognize the difference between signal artifact and valid
bio-signals caused by movements, interference, or misplacement of sensors or electrodes in dia-
gnosis and treatment of neurological diseases. The user should possess knowledge of elec-
trophysiology, including instrumentation, quantification, and statistical analysis. This manual
provides an operational summary for the Arc system. It does not provide clinical training. The
proper use of this device, for its intended use, can only be assured once all instructions have been
read and understood. User manuals, operator manuals, etc. are provided in English. Translations
will be provided based on local language requirements. Contact Cadwell with Arc operational
questions.
24. Do not use the system in an MRI environment.
25. Use only Cadwell authorized cables and accessories.
26. The system is not designed to operate in an explosive environment.
27. A possible loss of data can occur if acquiring data on a machine that has a network data folder.
28. Do not immerse the amplifier, remote input box, power-communications module, flash stim-
ulator, and system cables in liquid.
29. Do not use power strips with the system unless they are connected downstream of an isolation
transformer.
30. The system is designed to be used with one patient at a time. Do not connect multiple patients to
one amplifier.
31. Per the sensor manufacturer, circulation distal to the pulse oximetry sensor site should be
checked routinely. The site must be inspected every 8 hours to ensure adhesion, skin integrity
and correct optical alignment. If skin integrity changes, move sensor to another site.
32. Use only Cadwell recommended pulse oximeter sensor. Use of other sensors will result in
degraded performance or incorrect results.
33. Excessive movement may cause interference or affect accuracy of the SpO2 measurement.
34. A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oxi-
meter monitor.
35. Pulse oximeter equipment measurements are statistically distributed, only about two-thirds of
pulse oximeter equipment measurements can be expected to fall within +/- Arms of the value
measured by a CO- oximeter.
36. Misapplication of a pulse oximeter probe with excessive pressure for prolonged periods can
induce pressure injury.
37. Responsible organization and/ or operator needs to verify the compatibility of the monitor,
probe, and cable before use, otherwise patient injury can result.
38. Only the following probe and sensor (Nonin 8000 SS, SM, SL, and 3012LP XPOD) are intended to
be used with the Cadwell EEG system.
39. The Cadwell Oximeter is not intended to be used as a critical care decision device. It acquires sec-
ondary oximetry data for long-term analytical decisions and is intended to be used in combination
with EEG acquired information.
40. Do not connect items which are not specified as part of or for use with the Arc system.
41. When attaching the electrodes to a patient, verify that the subject will not become entangled in
the wires. Cadwell offers multiple lengths of cable to accommodate different clinical applications
and patient sizes.
42. Do not allow the electrode wires to wrap around the patient's neck.
43. Never place an isolation transformer on the ground.

44. Do not exceed the medical isolation transformer maximum load.

45. Do not use the isolation transformer to power non-system components; it may overload the trans-
former or defeat the separation by providing additional leakage sources.
46. Do not plug non-medical electrical equipment in the patient environment directly into a wall out-
let. This may cause excessive leakage current in the patient environment.
47. Software tools in Arc allow Arc records to be moved, managed, and deleted. The end user must
manage and archive records safely for retrieval.
48. Conductive parts of electrodes and associated connectors for applied parts, including the neutral
electrode, should not contact other conductive parts including earth.
49. Do not use the system if any component has physical damage.
50. Do not autoclave.
51. Discontinue using any module or sensor if the patient exhibits any allergic reactions to adhesive
or materials.
52. When applying the stockinette to the patient, verify that the stockinet is not covering the
patient’s eyes, nose, mouth, or ears. Verify that the stockinette does not entangle the patient’s
neck, restrict airflow, or restrict circulation.
53. The electrodes connected to the amplifier will be patient contacting, however they are not part of
the Essentia IEC 60601 evaluation. The user is free to buy electrodes from any electrode man-
ufacturer.
54. Components of the system are not intended to be patient contact devices.
55. Warning. The Arc Essentia does not incorporate means to protect the patient against burns when
used with High Frequency (HF) surgical equipment. Connection of patient to high frequency elec-
trosurgical equipment and electroneurodiagnostic equipment simultaneously may result in burns
at the site of the amplifier electrodes, and possible damage to the amplifier. Make sure that the
neutral electrode of the HF surgical device is properly placed and that it is making proper contact
with the patient. Consult HF Surgical device instruction for use.
Any serious incident that has occurred in relation to the device should be reported to the man-
ufacturer and the competent authority of the Member State in which the user and/ or patient is
established.

Symbols and Meanings

Symbol Title/ Meaning Reference
Attention, consult accompanying documents. IEC 348, EN
980
Serial number, includes date of manufacture. EN 980
Catalog number (part number) EN 980
Power LED Indicator IEC 878
Type BF equipment. Isolated patient connection IEC 878

Isolated patient ground input. Cadwell
convention
USB symbol Industry
convention
DC Input Cadwell
convention
Run/ Stop Cadwell
convention
Consult Instructions for Use IEC 60601-
1
EMG/EP/EEG equipment with respect to electric shock, fire, and mech- ITS
anical hazards only in accordance with UL 2601-1 and CAN/CS A C22.2 No.
601-1
CE Mark of compliance with the provisions of European Council directive MDD, MDR
93/42/EEC concerning medical devices (applies only to equipment so
marked and only in the countries stated on the declaration of conformity
for the device). Notified Body Number (0344), DEKRA.
Manufacturer MDD,
MDR,
15223
European Authorized Representative EN 980
Waste Electrical and Electronic Equipment Recycle or dispose of equipment WEEE

according to country regulatory requirements
Indicates device is a medical device MDR
Indicates UDI label 15223

Symbol Title/ Meaning Reference

Single use only 15223
IP22 Designates the level of ingress protection of an electrical enclosure against IEC 60529
intrusion of either solid objects, dust, or moisture1
Warning, electricity ISO 7010-
W012
Input IEC 878
Output IEC 878
Fragile Medical Equipment Do Not Drop Cadwell

convention
(Device
Packaging)
Humidity Range 10% to 90% Non-Condensing Cadwell
convention
(Device
Packaging)
Audible sound is heard when circuit is closed Cadwell
convention
Impedance button. This button can be pressed to initiate impedance or Industry

end impedance and resume recording. The associated LED indicates the convention
device is in impedance mode.
Start Recording button. This button can be pressed to put the device in Cadwell
recording mode. The associated LED indicates that the device is recording. convention
Electrode continuity check Cadwell

convention
1The first digit “2” designates ingress protection of objects 12.5 mm or larger; for example, fingers or
similar objects. The second digit “2” indicates protection against dripping water when the enclosure is
tilted at an angle up to 15° from the normal position.

Date of Manufacture
Year and Month of Manufacture
The year and month of manufacture, format YYYY-MM, can be derived from the device serial numbers
found on the Essentia device label(s) as follows:
XXXXXX | XX | X | X | XX | XX | XXX
For example, the following serial number equates to date of manufacture 2017-08 (YYYY-MM)
XXXXXX | XX | X | X | 08 | 17 | XXX

Essentia Essential Performance
The Essentia EEG system complies with all the essential performance requirements stated in IEC 60601-
2-26:2012, namely:
l 201.12.1.101.1 Accuracy of signal reproduction

l 201.12.1.101.2 Input dynamic range and differential offset voltage
l 201.12.1.101.3 Input noise
l 201.12.1.101.4 Frequency response
l 201.12.1.101.5 Common mode rejection
Essential performance can be verified by the following:
• Cadwell Industries, Inc. will verify essential performance during any preventative maintenance or ser-
vice routines.
• The user can verify essential performance requirements using the test procedures and pass/ fail cri-
teria outlined in Section 201.12.1.101 of IEC 60601-2-26:2012.
HIPAA Compliant access rights and auditing are included with the software. Each time a patient file is
accessed, the user ID is added to the user channel events. Events are auto-detected and stamped with
the user ID.
SpO2 Essential Performance

The System complies with the essential performance requirements as stated in ISO 80601-2-61, Sub-
clause 201.12.1 Accuracy of pulse oximeter (SpO2, Pulse Rate accuracy)
The SpO2 accuracy of the pulse oximeter is the root-mean-square difference of less than or equal to 4.0
% SpO2 over the range of 70 % to 100 % of SaO2. Accuracy determination is in accordance with ISO
80601-2-61, sub-clause 201.12.1.101.1
Pulse rate accuracy is stated as the root-mean-square difference between paired pulse rate data recor-
ded with the pulse oximeter equipment and with a reference method. Accuracy determined in accord-
ance with ISO 80601-2-61, sub-clause 201.12.1.104.

Maintenance Information
Factory Calibration
It is recommended to have Essentia EEG Systems calibrated annually. The Essentia system is calibrated
at Cadwell Industries, Inc. No additional hardware calibration is needed.
Regular preventative maintenance never involves access to the interior of the Essentia system. It
involves regular inspection and cleaning of Essentia components.
Arc Essentia essential performance can be verified by the following:

l Cadwell Industries, Inc. will verify essential performance during any preventative maintenance or
service routines.
l The user can verify essential performance requirements using the test procedures and pass/fail
criteria outlined in Section 201.12.1.101 of IEC 60601-2-26:2019.

HIPAA Compliant access rights and auditing. Each time a patient file is accessed, the user ID is added to
the user channel events. Events are auto-detected and stamped with the user ID.
Essentia Specifications and Operating Environment and Limits
Refer to Essentia Specification document 100870-931 for detailed specifications.
The Arc Essentia meets the following internationally recognized safety standards for Medical Electrical
Equipment:
l IEC 60601-1: 2012 General Requirements for Basic Safety and Essential Performance
l CSA C22.2#60601-1: 2008 (CB Scheme) General Requirement for Basic Safety and Essential Per-
formance
l IEC 60601-1-2: (2014) Collateral Standard – Electromagnetic Compatibility
l IEC 60601-2-26:2019 Particular requirements for the basic safety and essential performance of
encephalographs
l IEC 60601-1-6:2010 (Third Edition) + A1:2013 Collateral Standard: Usability ISO 80601-2-61:2011
Particular Requirements for pulse oximeter equipment

l IEC 62366:2007 (First Edition) + A1:2014 Application of usability engineering to medical devices
l IEC 62304:2006 (First Edition) Medical device software life-cycle processes
Regulatory Classification Information

l United States: Class II
l Canada: Class II
l European Union: Class IIa (Annex IX, Rule 10)
Type of Protection against Electric Shock

l Internally powered ME Equipment (USB powered)
Degree of Protection against Electric Shock

l Type BF Equipment (Floating Inputs)

Mode of Operation
l Continuous

Safety
SAFETY REQUIREMENTS & ALLOWABLE IEC 60601-1-1 SYSTEM CONFIGURATIONS
GENERAL DISCUSSION
The application of modern electronic technologies in medical practice has led to systems of medical and
non medical electrical equipment being used together for the diagnosis and monitoring of patients.
MEDICAL ELECTRICAL EQUIPMENT complying with IEC 60601-1 such as Cadwell equipment and accessor-
ies are often connected to other, non medical electrical equipment such as computers and printers.
Non-medical electrical equipment may fully meet the requirements applicable in their specific field, but
may not comply with isolation or leakage requirements for MEDICAL ELECTRICAL EQUIPMENT and
thereby impact the safety of the entire MEDICAL ELECTRICAL SYSTEM.
The following configurations ensure that combinations of Cadwell devices and non-medical electrical
equipment comply with the electrical safety requirements for MEDICAL ELECTRICAL SYSTEMS.
ALLOWABLE CADWELL SYSTEM CONFIGURATIONS

1. All Cadwell equipment and accessories are permissible in the PATIENT ENVIRONMENT without
incorporating a SEPARATING TRANSFORMER.
2. A double insulated Laptop Computer powered from Cadwell equipment is permissible in the
PATIENT ENVIRONMENT without incorporating a SEPARATING TRANSFORMER.
3. Other computing devices (i.e. desktop computer, monitor, printer, camera, IR illuminator etc.) are
NOT allowed in the PATIENT ENVIRONMENT unless a SEPARATING TRANSFORMER is used to
power those devices.
4. Non medical devices (examples in #3 above) may be used outside the PATIENT ENVIRONMENT
within the MEDICALLY USED ROOM without incorporating a SEPARATING TRANSFORMER,
provided each individual device is plugged into a FIXED MAINS SOCKET OUTLET. Otherwise a
SEPARATING TRANSFORMER must be incorporated.
5. MULTIPLE PORTABLE SOCKET OUTLETS (such as non-permanently attached power strips, unin-
terruptible power supplies {UPS}, and line conditioners) are not permitted in a MEDICALLY USED
ROOM unless connected to the output of a SEPARATING TRANSFORMER.
6. Connection to hospital networks is allowed without incorporating a SEPARATING DEVICE as long
as the network server and the MEDICAL ELECTRICAL SYSTEM are connected to circuits powered
from and grounded to the same electrical service entrance.
7. Disconnection from the supply mains is achieved through the mains disconnect of the computer
(power ON/OFF switch; or by unplugging the detachable AC power cord). Please refer to the
instructions for use provided with the computer.
SYSTEM REQUIREMENTS
Any SEPARATING TRANSFORMER (ISOLATION TRANSFORMER) incorporated into a MEDICAL ELECTRICAL
SYSTEM to meet the requirements herein must be approved to IEC 60601-1.
Non medical electrical equipment used in MEDICAL ELECTRICAL SYSTEMS must meet their respective IEC
electrical safety requirements, i.e. IEC 60950 for computing devices.
ENCLOSURE LEAKAGE must not exceed 500uA in any SINGLE FAULT condition within the PATIENT
ENVIRONMENT.

ENCLOSURE LEAKAGE must not exceed 100uA in normal condition.

EARTH LEAKAGE must not exceed 500uA in any single fault condition within the PATIENT
ENVIRONMENT.
The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 1500 volts isolation between patient and
earth.
The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 4000 volts isolation between patient
applied parts and mains voltage.
The MEDICAL ELECTRICAL SYSTEM must provide a minimum of 1500 volts isolation between non-patient
contact parts of the SYSTEM and mains voltage.
GENERAL WARNINGS AND PRECAUTIONS

1. DO NOT place ISOLATION TRANSFORMERS or MULTIPLE PORTABLE SOCKET OUTLETS on the
ground.
2. DO NOT connect MULTIPLE PORTABLE SOCKET OUTLETS (power strips) to the system, unless con-
nected downstream of an isolation transformer.
3. DO NOT connect items which are not specified as part of or for use with the SYSTEM.
4. DO NOT exceed the medical isolation transformer placarded maximum load.
5. DO NOT use medical isolation transformer provided with the system to power non-system com-
ponents as this can overload the transformer, or defeat the separation by providing additional
leakage sources.
6. DO NOT plug non-medical electrical equipment intended for use in the PATIENT ENVIRONMENT
directly into a wall outlet as this can potentially result in excessive leakage current present in the
patient environment.
DEFINITIONS
1. MEDICAL ELECTRICAL EQUIPMENT: Electrical equipment, provided with not more than one con-
nection to a particular supply mains and intended to diagnose, treat, or monitor the patient
under medical supervision and which makes physical or electrical contact with the patient and/ or
transfers energy to or from the patient and/ or detects such energy transfer to or from the
patient.
2. MEDICAL ELECTRICAL SYSTEM (SYSTEM): combination of items of equipment, at least one of
which must be MEDICAL ELECTRICAL EQUIPMENT and interconnected by functional connection or
an ISOLATION TRANSFORMER.
3. PATIENT ENVIRONMENT: any volume of space (area) in which intentional or unintentional contact
can occur between PATIENT and parts of the SYSTEM or between PATIENT and other persons
touching parts of the system. For practical purposes this is an area 1.5 meters or 5 feet beyond
reach of the patient.
4. MEDICALLY USED ROOM: the room in which the PATIENT ENVIRONMENT is located.
5. SEPARATING TRANSFORMER: medical ISOLATION TRANSFORMER designed to limit transfer of
unwanted leakage current and allow non-IEC 60601-1 devices to be located in the PATIENT
ENVIRONMENT.
6. SEPARATING DEVICE: a component or arrangement of components with input parts and output
parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of
the MEDICAL ELECTRICAL SYSTEM.
7. FIXED MAINS OUTLET: permanently installed (hard wired) grounded outlet in a facility.

8. MULTIPLE PORTABLE SOCKET OUTLET (power strips): a combination of two or more socket-out-
lets intended to be connected to, or integral with, flexible cables or extension cords.
9. SINGLE FAULT: Condition in which a single means for protection against a safety hazard in the
SYSTEM is defective or a single external abnormal condition is present.
Contact Cadwell Industries, Inc. Quality/ Regulatory Department with any questions regarding these
requirements.

Essentia Electromagnetic Emission and Immunity to Electromagnetic

Disturbances
This medical electrical equipment requires special precautions regarding Electromagnetic Compatibility
(EMC) and needs to be installed and put into service according to the EMC information provided below.
Portable and Mobile RF communications equipment can affect medical electrical equipment.
Use of accessories and cabling other than those specified below, with the exception of those sold by Cad-
well as replacement parts, may result in increased emissions or decreased immunity of the Essentia sys-
tem.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Essentia system is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of the Essentia should assure that it is used in such an environment.
IEC 60601-1-2:2014
Emission Test Compliance Electromagnetic Environment Guidance
Radiated Emis- Class B The Arc Essentia System uses RF energy only for its internal function.
sions Therefore, its RF emissions are very low and are not likely to cause
CISPR 11 any interference in nearby electronic equipment.
Conducted Emis- Class B The Arc Essentia system is suitable for use in all establishments dir-
sion CISPR 11 ectly connected to the public low voltage power supply network that
supplies buildings used for domestic purpose.
WARNING: Portable RF communications equipment (including peri-
pherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of Arc Essentia,
including cables specified by the manufacturer. Otherwise, degrad-
ation of the performance of this equipment could result.
Harmonic Dis- Complies Cadwell declares the Essentia system does not produce harmonic dis-
tortion IEC tortion emissions above established limits.
61000-3-2
Voltage fluc- Complies Cadwell declares the Essentia system does not produce voltage fluc-
tuations - flicker tuations or flicker emissions above established limits.
emissions IEC
61000-3-3
The Essentia system should not be stacked with any other equipment. If stacked use is necessary, per-
formance of the system should be observed to verify normal operation in the configuration in which it
will be used.
Guidance and Manufacturer’s Declaration – Electromagnetic Disturbances
The Essentia system is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of the Essentia should assure that it is used in such an environment.
IEC 60601-1-2:2014
Electromagnetic Compliance Electromagnetic Environment Guidance


Disturbance Test
Electrostatic Dis- +/- 8 KV contact ESD produces noise glitches on the Essentia System.
charge. +/- 15 KV air These noise glitches are easily differentiated from
IEC 61000-4-2 biopotential input signals. ESD noise is unavoidable in
high-static environments due to the high input sens-
itivity of the equipment. To minimize electrostatic
effects, floors should be wood, concrete or ceramic
tile, relative humidity should be 30%.
Radiated RF EM 3 V/m, Portable and mobile RF communications equipment
Fields IEC 80 MHz – 2.7 GHz should be used no closer to any part of the Essentia
610000-4-3 System, including cables, than the recommended sep-
aration distance calculated from the equation applic-
able to the frequency of the transmitter, see Table 1.
Disturbances System complies with all IEC Portable and mobile RF communications equipment
from RF wireless 60601-1-2:2014 requirements should be used no closer to any part of the Essentia
communications specified in Table 9 System, including cables, than the recommended sep-
equipment. aration distance calculated from the equation applic-
able to the frequency of the transmitter, see Table 1.
Electrical Fast AC mains +2KV, 100 KHZ PRF EFTs may cause events in the displayed waveforms.
Transients (EFT) AC mains -2KV, 100 KHZ PRF This is an unavoidable phenomenon due to the high
IEC 610000-4-4 input sensitivity of the equipment. These waveform
disturbances can be differentiated from physiological
events. To minimize these effects, mains power qual-
ity should be that of a typical commercial or hospital
environment.
Surge IEC 610000- +2KV, -2KV Line to Gnd Surges may cause events in the displayed waveforms.
4-5 This is an unavoidable phenomenon due to the high
input sensitivity of the equipment. These waveform
disturbances can be differentiated from physiological
events. To minimize these effects, mains power qual-
ity should be that of a typical commercial or hospital
environment.
Conducted 3V, 0.15 MHZ to 80 MHz. Conducted disturbances may cause events in the dis-
Immunity IEC 6V in ISM bands between played waveforms. This is an unavoidable phe-
610000-4-6 0.15MHz and 80 MHz 80% nomenon due to the high input sensitivity of the
AM at 1 KHz equipment. These waveform disturbances can be dif-
ferentiated from physiological events. To minimize
these effects, mains power quality should be that of a
typical commercial or hospital environment.
Magnetic 30 A/m 50 Hz, 60 Hz Magnetic disturbances higher than 30 A/m may cause
Immunity IEC events in the displayed waveforms. This is an unavoid-
610000-4-8 able phenomenon due to the high input sensitivity of
the equipment. These waveform disturbances can be


differentiated from physiological events. To minimize
these effects, mains power quality should be that of a
typical commercial or hospital environment.
Arc Essentia system does comply with IEC 80601-2-
26:2019 Essential performance, 201.12.1.106 Com-
mon
Voltage Dips IEC 0 % UT; 0.5 cycle g At 0°, 45°, Voltage dips may cause events in the displayed wave-
61000-4-11 90°, 135°, 180°, 225°, 270° forms. This is an unavoidable phenomenon due to the
and 315° high input sensitivity of the equipment. These wave-
0 % UT; 1 cycle form disturbances can be differentiated from physiolo-
70 % UT; 25/30 cycles single gical events. To minimize these effects, mains power
phase at 0° quality should be that of a typical commercial or hos-
pital environment.
Voltage Inter- 0 % UT; 250/300 cycle For long interruptions the system maintains its func-
ruptions IEC tionality if the Arc Essentia is powered from a laptop
61000-4-11 and the laptop battery is charged.
Table 1
Recommended separation distances between portable and mobile RF communications equipment
and the Cadwell Essentia
The Essentia system is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. The customer or the user can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (trans-
mitters) and the system as recommended below, according to the maximum output power of the com-
munications equipment.
Rated maximum output power of Separation distance according to frequency of transmitter m
transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 d = 0.12 m d = 0.12 m d = 0.23 m

0.1 d = 0.38 m d = 0.38 m d = 0.73 m
1.0 d = 1.2 m d = 1.2 m d = 2.3 m
10 d = 3.8 m d = 3.8 m d = 7.3 m
100 d = 12 m d = 12 m d = 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation dis-
tance d in meters (m) can be estimated using the equation applicable to the frequency of the trans-
mitter, 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 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

NOTE 3 Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted the-
oretically 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 Essentia system is used exceeds the applicable RF compliance level of IEC 60601-1-2:2014,
the Essentia system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the system.

Essentia Cleaning Instructions
Always disconnect all components from power before cleaning.
Perform cleaning and disinfection procedures on a per-use basis in compliance with your company infec-
tion control policy to ensure the safe operation of your Essentia system. As you clean, visually inspect
the instrument and its components for damage or wear. Contact Cadwell if you notice damage to the
exterior of the instrument. Do not attempt to service or repair damaged or inoperable equipment. If you
suspect a problem, contact the Cadwell Service Department at 800-245-3001.
While the Essentia system has been carefully designed and manufactured to be as reliable and durable
as possible, regular cleaning and inspection of the system components can help the long term, trouble-
free operation of the system. Do not use abrasive cleaners. Try to avoid extremes of physical stress such
as dropping the unit or exposing it to extreme temperatures.
Cadwell recommends that you refer to the AAMI Standards and Recommended Practices for Ster-
ilization in Health Care Facilities, or equivalent standard text for detailed disinfection instructions.
These standards may be ordered by calling the Association for Advancement of Medical Instrumentation
at (703) 525-4890. www.aami.org
The Essentia amplifier and recorder, Photic Stimulator, Microphone, Patient Event Button, harness,
zippered pouch, and cables may be disinfected with an intermediate level surface disinfectant, but cer-
tain cleaning agents may have a degrading effect on your equipment. The following list indicates clean-
ing products recommended by the plastic manufacturer as not causing degradation of the plastic
housing:
l Clinell Universal Wipes
l Clorox Bleach (1:10 min water)
l Clorox Healthcare Bleach Wipes
l Clorox Healthcare Hydrogen Peroxide Wipes
l Hand Soap
l Hydrogen Peroxide (3%)
l Isopropanol 70%
l Lysol Infection Control Quaternary Cleaner (working concentration)
l Sani-Cloth Bleach
l Seventh Generation Disinfecting Wipes
l Sporicidin
l Super Sani-Cloth
l Vesphene (working concentration)
l Virex II 256 (working concentration)
l Windex (blue)
The use of the following cleaners/ disinfectants may cause degradation of the plastic housing:
l Acetone
l Activated Hydrogen Peroxide (AHP)
l CaviCide

l CaviWipes
l Clorox Disinfecting Wipes (lemon)
l Formula 409 Cleaner Degreaser
l Envirocide
l Lysol Disinfecting Wipes
l Micro-Kill One Germicidal Wipes
l Opti-Cide Healthcare Wipes
l Oxivir TB
l Sani-Cloth HB
l Sani-Cloth Plus
l Sani-Cloth AF3
l Virex TB
Follow product specific disinfectant instructions found on labels. Keep all cleaning fluids away from elec-
trical connectors. Do not let solutions seep inside the unit.
Disposal of Equipment
At the end of product life, please decontaminate the equipment before decommissioning.
Please dispose of equipment under the regulatory requirements of your country. Packaging materials
may be re-used. For the EU, disposal has to take place in conformance with the WEEE directive
(2012/91/EU).
Warranty Information
Refer to Cadwell warranty document 829001-000 Cadwell 1-Year Warranty and Service Information that
shipped with your system for details.
For equipment warranty details and extended service package information, please see Cadwell's Terms
of Service at www.cadwell.com/terms
Electrode Catalog and eStore

Cadwell has an online electrodes catalog and eStore. Cadwell representatives are available to take your
order at 800-245-3001.
Cadwell eStore: www.estore.cadwell.com

Customer Support and Contact Information

www.cadwell.com
US Customers
Phone: 1-800-245-3001 or 509-735-6481
Fax: 509-783-6503
Service Support
Monday - Friday, Pacific Standard Time (PST)
Normal business hour: 6:30 a.m. – 5:00 p.m.
For service-related issues, phone support is provided free of charge for the life of your instrument
service@cadwell.com
Application Support
Monday - Friday, Pacific Standard Time (PST)
Normal Business Hours: 6:30 a.m. – 5:00 p.m.
24/7/365 support available for PSG, EEG, and EMU.
Call Application Support if you experience difficulty after troubleshooting a problem.
applications@cadwell.com
International Customers
Please contact your distributor directly or email at International@cadwell.com
EU Importer
Cadwell Europe GmbH
Maximilianstr. 54
80538 Muchen, DE
International@cadwell.com
Remote Assistance
Remote assistance and troubleshooting is available for systems under warranty or service contract. With
your permission, a support technician can establish a secure connection to your Cadwell instrument via
the internet.
Please call the service department or application support department. A support or service technician
will verify your account information and guide you through the steps to begin a remote assistance ses-
sion.


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User Guide Essentia EEG System

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Essentia User Guide 100870-639 Rev 07

© 2021 Cadwell Industries, Inc. 1

Copyright and Disclaimer Information

© 2021 Cadwell Industries, Inc. 2

© 2021 Cadwell Industries, Inc. 3

© 2021 Cadwell Industries, Inc. 4

© 2021 Cadwell Industries, Inc. 5

Intent, Overview, Indications for Use

Cadwell on the Web: www.cadwell.com

© 2021 Cadwell Industries, Inc. 6

Essentia Indications for Use

© 2021 Cadwell Industries, Inc. 7

Arc Essentia Setup Instructions

Unpacking the System

You should receive the following as standard items:

1. Arc Essentia Amplifier (E1A or E3A)

Optional Accessories for Essentia EEG Systems

© 2021 Cadwell Industries, Inc. 8

Arc Essentia Amplifier Options

E1A for Private Practice

© 2021 Cadwell Industries, Inc. 9

Connections and Power Instructions

1. Power on the computer and monitor.

To turn the equipment off:

Turn off equipment in the following order:

Connecting USB Pulse Oximeter and Probe Sensor:

1. Connect the USB Oximeter 3012LP to the acquisition PC USB port.

© 2021 Cadwell Industries, Inc. 10

Computer, Network, IT Security

PC Purchased from Cadwell

Configuration of Non-Cadwell Supplied Computers

Arc Reference Documents

Network and Storage Requirements

© 2021 Cadwell Industries, Inc. 11

See 369044-624 CadLink System Configuration for more information.

Antivirus Software and Disk Encryption Software Applications

Authorized User Access

It is necessary to run the software as intended.

l The use of anti-virus and anti-malware software.

l The use of firewalls.

l Unplug the computer, especially if unable to disconnect from the network.

l Contact IT department immediately.

© 2021 Cadwell Industries, Inc. 12

Arc Application Instructions

To Close the Arc program

© 2021 Cadwell Industries, Inc. 13

Essentia Setup Verification

© 2021 Cadwell Industries, Inc. 14

3. You will see this screen as it loads:

© 2021 Cadwell Industries, Inc. 15

6. Let the traces display and record for five minutes.

Reviewing the Recording

© 2021 Cadwell Industries, Inc. 16

Additional Help Resources

© 2021 Cadwell Industries, Inc. 17

© 2021 Cadwell Industries, Inc. 18

report, they select OK.

Yes if done or No to go back and resolve more items.

© 2021 Cadwell Industries, Inc. 19

Report Generation Controls

Help: This option opens the Help Files.

© 2021 Cadwell Industries, Inc. 20

Release Note Reference

© 2021 Cadwell Industries, Inc. 21