Apollo+ User Guide 100871-639 Rev.

07

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 Apollo+ User Guide 100871-639 Rev. 07

Copyright and Disclaimer Information

© 2022 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, elec-
tronic, 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. Cadwell 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 Apollo+
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 peri-
odically made to the information herein; these changes will be incorporated into future revi-
sions of this document. 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 soft-
ware from Cadwell Industries, Inc.

Cadwell also expressly disclaims all liability for direct, indirect, special, incidental or con-
sequential damages, 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 res-
ult 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 Apollo+, 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 constitute a waiver of Cadwell’s trademark or other intellectual

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property rights concerning that name or logo. Other brand and product names are trademarks
or registered trademarks of their respective holders.

Cadwell Industries, Inc. reserves the right to modify, delete, extend, or improve features
described herein without notice.

Patents
www.cadwell.com/patents

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Table of Contents
Copyright and Disclaimer Information 2
Disclaimer 2
Trademark Notices 2
Patents 3
Table of Contents 4
Intent, Overview, Indications for Use 7
User Guide Intent Statement 7
References 7
Arc 7
CadLink 7
Synopsis 7
EEG Hardware 7
General 7
Overview 8
Apollo+ Indications for Use 8
Intended Use and Environment 8
Apollo+ Setup Instructions 9
Unpacking the System 9
Standard Apollo+ Components 9
Connections and Power Instructions 12
To turn the equipment on 12
To turn the equipment off 13
Apollo+ Batteries 13
Removal of Batteries 14
Installation of Batteries 14
Charging of Batteries 14
Computer, Network, IT Security 16
Computer Requirements 16
PC Purchased from Cadwell 16
Computer Peripherals 16
Configuration of Non-Cadwell Supplied Computers 16
Arc Reference Documents 16
Network and Storage Requirements 17
Antivirus Software and Disk Encryption Software Applications 17
Authorized User Access 17
System Cybersecurity 17
Arc Application Instructions 19
Opening and Closing Arc Software 19
To Open the Arc program 19

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To Close the Arc program 19

Connecting USB Pulse Oximeter and Probe Sensor 19
Apollo+ Hardware Overview 20
Apollo+ System 20
Apollo+ Recorder 21
Recorder Buttons 21
Unlocking the Recorder 21
Imped 22
Lock 22
Stop 22
Apollo+ 32 Channel Amplifier 23
Apollo+ 64 Channel Amplifier 24
Q-Video Mobile 3 24
QVM3 Indicators / Controls 25
(1) Ambient light sensor 25
(2) Battery status indicator 25
(3) Charging indicator 25
(4) Power button 25
Apollo+ Setup Verification 27
EEG Protocol 27
Reviewing the Recording 29
Generating a Report, Closing the Recording, and Reviewing the Report. 30
Additional Help Resources 32
Generating Reports 33
Narrative Resolver 34
Report Generation Controls 35
Release Note Reference 36
Apollo+ Warnings and Cautions 37
General Warnings and Cautions 38
Symbols and Meanings 42
QVM3 Warning Symbols 44
Date of Manufacture 45
Year and Month of Manufacture 45
Revision and Configuration 45
Apollo+ Essential Performance 46
SpO2 Essential Performance 46
Maintenance Information 47
Factory Calibration 47
Service Life 47
Apollo+ Specifications and Operating Environment and Limits 47
Additional QVM3 Specifications 48
Mechanical 48

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Environmental Operating Limits 48

Safety 49
Apollo+ Electromagnetic Emission and Immunity to Electromagnetic Disturbances 52
Apollo+ Wireless Protocols and Specifications 55
Operating Channels 56
Apollo+ Wifi module 56
Quality of Service and security recommended for use with Apollo+ wireless 57
Wireless performance 57
Limitations 57
Compliance with wireless coexistence standards 57
Apollo+ Cleaning Instructions 58
Disposal of Equipment 59
Warranty Information 59
Electrode Catalog and eStore 60
Customer Support and Contact Information 61
US Customers 61
Service Support 61
Application Support 61
International Customers 61
EU Importer 61
Remote Assistance 61

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Intent, Overview, Indications for Use

User Guide Intent Statement 
This device is intended for qualified users only. Refer to your institution’s policy regarding par-
ticular 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
following 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

Synopsis
369049-639 Synopsis User Guide
369045-950 Arc Synopsis Technical Document

EEG Hardware
100871-621 Apollo Technical Manual
100871-930 Apollo System Document
100871-931 Apollo Spec Sheet
100840-931 Easy III EEG Specification Sheet

General
308014-000 Minimum Computer Specifications

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Cadwell on the Web: www.cadwell.com

Overview
The Apollo+ is an electroneurodiagnostic medical device which measures and displays the elec-
trical signals generated by the nervous system. It acquires the data necessary to perform EEG
testing.

Apollo+ is intended to be used by personnel trained to perform the intended tests. The system
is used primarily in a home, clinical and hospital setting to diagnose neurological abnormalities.

Apollo+ Indications for Use

The Cadwell Apollo+ system is indicated for prescription use to acquire, record, transmit, and
display physiological and environmental data for electroencephalographic (EEG) and poly-
somnographic1 (PSG) ambulatory and/ or clinical studies of patients of all ages.

Intended Use and Environment

The Cadwell Apollo+ system consists of:
(1) acquisition hardware that can acquire, record, store, and transfer EEG data, patient event
button signal, audio signals from a microphone, and LCD display
l The Apollo+ 32 Channel Amplifier acquires 32 EEG data channels with 3 active-reference

inputs
l The Apollo+ 64 Channel Amplifier acquires 64 EEG data channels with 8 active-reference

inputs
(2) software that allows a user to acquire, store, transmit, view and print data, and to create
reports based on the acquired data
(3) optional video recording
(4) an optional photic stimulator
(5) a host electronic device (typically a PC) capable of running the software and interfacing with
the acquisition, video recording, and photic stimulation devices.

The Apollo+ system is intended for home use and a professional healthcare environment.

1CE mark does not apply to PSG indications.

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Apollo+ Setup Instructions

Unpacking the System
Thank you for selecting the Cadwell Apollo+ system! It’s time to unpack the contents of your
system. 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.

Standard Apollo+ Components

Refer to Figure 1 for the steps below.
1. Apollo+ Recorder
2. Apollo+ 32 Channel or 64 Channel Amplifier
3. Apollo+ Instrumentation Cable
4. USB Cable
5. Apollo+ Battery Charger
6. Arc installation software CD or USB drive
7. If ordered, a laptop or desktop computer with AC adapter and/or AC power cables

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 soft-
ware. Please store media that shipped with your system in a secure location. These
were included as a back-up copy only. If a computer is purchased from a source other
than Cadwell, the Windows Operating System must be properly configured, and Arc Soft-
ware must be installed and activated. Refer to the Configuration of Non-Cadwell Sup-
plied Computers section below for detailed instructions.

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Figure 1 - Standard Apollo+ components

NOTE: The 64 Channel amplifier may be used with the rest of the Apollo+ system to achieve dif-
ferent clinical needs.

Please check for any optional items you may have ordered. These may include, but are not
limited, to the following. See Figure 2

1. Photic Stimulator
2. QVM3 Video Camera
3. Ambulatory Patient Microphone
4. Patient Event Button
5. Pole Clamp
6. Apollo+ Backpack Kit
7. Apollo+ Harness
8. USB Pulse Oximeter

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Figure 2 - Optional Apollo+ components

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Connections and Power Instructions

To turn the equipment on
Refer to Figure 1 for the steps below.
1. Power on the computer and monitor.
2. Connect the Apollo+ 32 or Apollo+ 64 channel amplifier to the Apollo+ Recorder with the
Apollo+ Instrumentation cable, you will hear a click when each connector is secured to
the amplifier and recorder.
3. Connect the Apollo+ Recorder to a USB port on the computer with the USB cable. Ensure
the USB C connector is fully connected.
4. Connect the patient event button to the side of the Apollo+ Recorder (optional).
5. Connect the ambulatory patient microphone to the 3-pin input jack on the Apollo+
Recorder (optional).
6. Connect electrodes into the touchproof connectors on the Apollo+ amplifier.
7. Connect the Arc photic stimulator to a USB port on the computer (optional).
8. Connect the QVM3 power adapter into the QVM3 power jack on the back of the unit.
Connect the QVM3 power adapter to AC power.
9. Turn the QVM3 on by depressing the power button on the front of the device.
10. Once the QVM3 has completely powered up, connect it to the computer using the USB
cable.
11. If USB Oximeter (SpO2) purchased, plug into the USB port on the computer.

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Figure 1 - Apollo+ Connections and Power

To turn the equipment off

1. Close the Arc program and any other related programs running on the computer.
2. Unplug all USB devices from the computer. The Apollo+ Recorder and Amplifier will auto-
matically enter standby mode when unplugged and not recording data.
3. Turn the QVM3 off by depressing the power button on the front of the device.
4. Shut down Windows.
5. Turn off monitor (for desktop configurations only).

Apollo+ Batteries
The Cadwell Apollo+ Recorder utilizes up to two batteries. A minimum of one battery is
required if the Apollo+ is disconnected from the USB connection. The batteries can be removed
and installed as follows.

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Removal of Batteries
1. Remove the flexible bumper on the bottom of the Apollo+ Recorder.
2. Remove the battery cover retaining screw from the battery cover underneath the flexible
bumper using an appropriate tool.
3. Remove the battery cover.
4. Remove one or both batteries from the Apollo+ Recorder. If both batteries are removed,
the device will turn off and stop recording until power is supplied to the Recorder (via bat-
teries or USB connection).

Installation of Batteries
1. Insert one or two batteries into the Apollo+ Recorder. Ensure the batteries are inserted
with correct alignment.

2. Insert the battery cover into the bottom of the Apollo+ Recorder.
3. Insert the battery cover retaining screw into the battery cover, and secure using an appro-
priate tool.
4. Place the flexible bumper onto the bottom of the Apollo+ Recorder.

Charging of Batteries
The Apollo+ batteries contained in the Apollo+ Recorder can be charged in one of the following
ways:
l Connect the Recorder USB port to the computer using the USB cable and trickle charge

(estimated time for charge is 31 hours).

l Remove the batteries from the Apollo+ Recorder and charge with the provided external

battery chargers (estimated time for charge is 4 hours).

NOTE: For additional information on external battery charging, refer to the instruction
manual provided with the external battery charger. For additional information on the

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Apollo+ Recorder Battery, refer to the instruction manual available at www.rrc-ps.-

com/manual1130.

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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 system, or the customer
may purchase 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 require-
ments.
NOTE: Installing Arc software on operating systems and computers that are not recom-
mended 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 soft-
ware. 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 Oper-
ating System must be properly configured, and Arc Software must be installed and activ-
ated.

Arc Reference Documents

The reference document 369045-934 Arc Installation Instructions will be provided with the sys-
tem or on the Arc media in the Documents folder. Follow the instructions to configure the com-
puter for use with Arc software.

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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 set-
ting. CadLink is designed to allow users to review data from home, office, lab, or anywhere an
internet connection 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 stor-
age 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 malicious programs. We also want you to protect the privacy of your patient data. Though
Cadwell has configured Arc software with multiple AV and disk encryption applications, we can-
not 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 credentials.

It is necessary to run the software as intended.

System Cybersecurity
To help address unwanted access or intrusions the following are highly recommended:

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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, the following
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.

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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.

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.

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Apollo+ Hardware Overview

Apollo+ System

Cadwell’s Apollo+ system is the mobile solution for Routine EEG, EMU, ICU, and At-Home mon-
itoring. Consisting of the Apollo+ Recorder and Apollo+ 32 Channel Amplifier, Apollo+ 64 Chan-
nel Amplifier, and QVM3 Video Recorder. The Apollo+ system provides unique features that can
improve data security, patient experience, and ease of use.

With a 1 MHz sampling rate, storage rates from 250 Hz to 2 kHz are user selectable. 32 chan-
nels or 64 channels of EEG are available, including 3 bipolar pairs for the 32 Ch Amplifier and 6
for the 64 Channel Amplifier.

With battery or USB power and built in memory, Apollo+ provides unparalleled freedom.
Patients within the hospital can disconnect from the acquisition PC and enjoy a high level of
mobility. When the patient is reconnected to the monitoring PC, the batteries are recharged,
and acquired data is immediately downloaded and available for review. This workflow allows
indefinite recording length.

In an ambulatory recording, more than three days of data acquisition is possible with no patient
intervention required.

Apollo+ also has a QuickStart feature, allowing a user to start a recording without using a PC. All
study downloads are initiated via Arc Software.

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The Apollo+ offers up to 4 programmable buttons that can be associated with Events, as well as
an external Patient Event switch. Apollo+ also supports the use of a lapel microphone, allowing
the patient an additional way to document Events and provide detailed information about their
experience.

Apollo+ Recorder

The Recorder powers the Apollo+ Amplifier and provides for the connection of other optional
accessories. As shown above, the Recorder has five buttons: a power button and four pro-
grammable buttons. The top of the Recorder has four connectors: a USB connector, a micro-
phone connector, and two amplifier connectors. An additional connection for the optional
patient event button is on the left side of the device. The LCD screen allows for easy interaction
with the device and displays device status information, including but not limited to, recording
status, battery capacity, impedance measures, and study markers. The provided elastomeric
bumpers help to increase durability and absorb shock from inadvertent drops.

Recorder Buttons
The programmable buttons may be used for starting/ stopping studies, checking impedances,
and marking events in a record. These buttons are programmed during the Study Type setup.

Unlocking the Recorder

At any point in time, the recorder can be unlocked by pressing and holding buttons 1 and 4 for
~5 seconds. During a recording, when you release the buttons, the screen will say Stop, Imped,
and Lock.

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NOTE: When using the features of the unlocked device, a period of inactivity will result
in the device either re-locking itself if a recording is in process, or the device going to
sleep if a recording is not in process.

Imped

Enter Impedance mode. This allows a user to check impedances using the LCD display without a
PC attached. When in Impedance mode, press Next to cycle through inputs, or Exit to exit
impedance mode.

Lock

Locks the device.

Stop

PRESSING STOP WILL STOP THE RECORDING! When Stop is pressed, the following options are
available: Start, Imped, Append, and Lock.
Start - Clears all data and starts a new recording
Imped - Prompt to clear all stored data, start a new recording, and enter impedance
mode.
Append - Resumes previously stopped recording without deleting any data.
Lock - Re-lock the device

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Apollo+ 32 Channel Amplifier

The Apollo+ 32 Channel Amplifier connects to the Recorder via an Apollo+ instrumentation
cable. The Amplifier is powered via the Apollo+ Recorder and must be connected to the
Recorder at all times during data acquisition. There are 32 input channels available with three
dedicated bipolar (active reference) pairs.

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Apollo+ 64 Channel Amplifier

The Apollo+ 64 Channel Amplifier connects to the Recorder via an Apollo+ instrumentation
cable. The Amplifier is powered via the Apollo+ Recorder and must be connected to the
Recorder at all times during data acquisition. There are 64 input channels available with eight
dedicated bipolar (active reference) pairs.

Q-Video Mobile 3
The Q-Video Mobile 3 device is an optional accessory that can be purchased to record HD video
and audio with ease in the patient home. Built in Infrared (IR) illumination and ambient light
sensing technology (1) allows the QVM3 to automatically switch between day and night record-
ing.

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QVM3 Indicators / Controls

(1) Ambient light sensor

Sensor controls the built-in IR lights. This allows for automatic switching between day and night
recording.

(2) Battery status indicator

This indicator illuminates solid orange when the device is charging. Batteries will last approx-
imately 18 hours on full charge (dependent on video quality). Fully depleted batteries will take
approximately 6 hours to charge.

(3) Charging indicator

This indicator illuminates solid green when the device is plugged in to AC power.

(4) Power button

This is the power button for the device. Depress the button with the use of a tool to turn device
on and off.
The device is setup and initialized via Arc software. The device connects to the acquisition PC
via a USB cable. Prior to beginning an EEG study, QVM3 is plugged in to the acquisition PC.

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When the study is started in Arc software, the QVM3 device automatically starts recording. At
this point, QVM3 can be disconnected from the acquisition PC and will continue to record.

Live video data can be seen on the LCD screen on the QVM3 device at all times during record-
ing. The provided external power cord allows patients to plug in and charge the device at home.
The device will give an audible alarm when the battery is running low to indicate to the user
that they need to charge the device. Patients should be advised to plug the device in at night in
order to charge the device and enable the IR illumination.

NOTE: The device must be plugged in to power in order for the built-in IR lights to illu-
minate.

When the study is completed, the Q-Video Mobile 3 should be plugged back into the PC to
download data. Download is initiated by Arc software and can be performed via USB. QVM3 fea-
tures a removable SSD hard drive to allow faster downloads for large data files. Cadwell offers a
SATA cable to download QVM3 data directly from the hard drive. Video data is reviewed via Arc
software.

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Apollo+ Setup Verification

EEG Protocol

Place recording electrodes to the scalp as desired according to the 10/20 international place-
ment system. The electrodes connect to the inputs on the Apollo+ amplifier via touchproof con-
nectors.

NOTE: Due to increased chance of DC saturation, Enhanced Lead Off Detection is not

recommended if invasive electrodes (e.g. subdermal needle electrodes) are used for
recording. This feature can be toggled on or off in the Administration Panel -> Study
Types -> Impedance panel.

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1. Select the Record tab at the upper left. You will be presented with this screen:

2. Select the desired study type button (study types are customizable) to start an ambulatory
study. 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. If Q-Video Mobile 3 was purchased
with the system, plug into USB port on computer and confirm that an orange Q shows up in the
study type button.

3. The trace window will automatically load.

4. Once the study is ready to begin, click the button at the upper left.

5. Select Calibration button from the top toolbar and run calibration for at least one
page to confirm signal integrity from system. Select this button again to exit calibration and
return to data acquisition.

6. 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.

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

8. Click on the Patient Info tab on the upper left side of the screen to bring up the cor-
responding window and enter additional information as necessary.

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9. 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 Studies tab in the main screen

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.
NOTE: 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.

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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.

Generating a Report, Closing the Recording, and Reviewing

the Report.

1. To generate a report, select the Reports button in the review top toolbar.

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2. Highlight a report from the Select Report list and click on Select.

3. A default name will be given to the report, though at this time the name can be changed if
desired. Select OK to continue.

4. For some of the reports, a narrative resolver will display in Word after the report generates,
make the selections and select OK.

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5. The report will display. Make any additional edits needed, then select Save and Exit.

6. To close the recording being reviewed, select the red X in the upper right-hand corner. Select
the status for the recording and then click OK.

7. To review the report at a later time, log in to the Arc application and select the Review
Records tab. Highlight the patient in the list and select the report from the associated doc-
uments list and then click View to open the report.

Additional Help Resources

Release notes (369045-810) can be found in the Documents folder on the software installation
disc/ USB (369045-200).

Help, Remote Assistance, Feature Request, and About can be accessed by left clicking on the
question mark in the upper right hand corner of the Arc application.
l Select Help to access the help files for the Arc software and hardware. The Help files con-

tain more detailed information about Arc Software features, including but not limited to
Keyboard Hotkeys, Sentinel Nurse Monitoring, Remote Control, Satellite View, and basic
Arc Software settings.
l Select About to view what software features are licensed, details of the acquisition

machine, hardware details and version of Arc software running.

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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.

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Narrative Resolver
l Check the box next to the paragraph that the user would like to have included in this par-
ticular 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 button 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 nav-
igate 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 cur-
rent selections.

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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 asso-
ciated signature for that user a prompt will appear. To associate a signature, navigate to the
users section in the Administration 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 Authentic-
ate. That authenticated Arc user's signature will then be inserted at the current cursor position
in the report.

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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
generated 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).

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Apollo+ Warnings and Cautions

1. Do not place Apollo+ Recorder on a television, radio, or CPAP device.
2. Use only Cadwell supplied batteries in the Cadwell Apollo+ Recorder. Replacement bat-
teries (PN 245019-000) are available from Cadwell.
3. Do not remove the SSD drive from Q-Video Mobile 3 if the device is actively collecting
data.
4. Do not remove battery from Q-Video Mobile 3 device. No user serviceable parts inside.
5. Do not crush, puncture, incinerate, short-circuit, disassemble, immerse in water, expose
to strong mineral oxides, or heat the Q-Video Mobile 3 battery to over 60 degrees
Celsius.
6. Exposure to battery contents may be harmful. In case of eye exposure, flush with water
for 15 minutes without rubbing and seek medical attention.
7. In the case of skin exposures to the battery contents, wash affected area with liberal
amounts of water for at least 15 minutes and seek medical attention.
8. In case of fire, use CO2, dry chemical powder or alcohol resistant foam extinguishers.
9. The Apollo+ EEG system is not recommended for use with high-frequency surgical equip-
ment.

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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
reconnection 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 resistant. The contact of liquids with the internal parts and connectors of the sys-
tem 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 hear-
ing 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 sur-
gical equipment may result in burns at the EEG electrode placement sites and/ or damage
to the EEG amplifiers 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 instructions 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 tech-
nicians 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
responsibilities for patient care and the user should not solely depend on network

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connection for patient care.

20. Caution must be taken when moving the cart with the arm as these arms can expand mak-
ing 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 the amplifier 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 diagnosis and treatment of neurological diseases. The user
should possess knowledge of electrophysiology, including instrumentation, quan-
tification, 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 inten-
ded 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
stimulator, 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 meas-
urement.
34. A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a
pulse oximeter monitor.

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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 mon-
itor, 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 inten-
ded 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 secondary 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 dif-
ferent 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 transformer 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 outlet. 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 Apollo+ device is intended to be worn over clothes and it is not intended to contact
the patient directly. The electrodes connected to the amplifier will be patient contacting,
however they are not part of the Apollo+ IEC 60601 evaluation. The user is free to buy
electrodes from any electrode manufacturer.
54. Components of the system are not intended to be patient contact devices.

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Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/ or
patient is established.

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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 mechanical ITS
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

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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)
Amplifier input connectors Cadwell
convention
1 Amplifier is mapped as amplifier 1 for Apollo+ recording Cadwell
convention
2 Amplifier is mapped as amplifier 2 for Apollo+ recording Cadwell
convention
Amplifier-Voice Event Connector Input for microphone Cadwell
convention
Patient Event Button input Cadwell
convention
Indicates plugged in to power via associated green LED Cadwell
convention
Associated LED indicates charging status when solid orange. The light is off Cadwell
when fully charged or not charging convention
Connector for power supply to charge QVM associated QVM devices 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.

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QVM3 Warning Symbols

Symbol Title/ Meaning Reference
Low Battery. Shown when the QVM3 battery has been almost fully depleted. Cadwell con-
vention

Hard drive removed. Shown when the SSD drive has been either removed or Cadwell con-
unmounted. vention

High temperature. Shown when the ambient temperature is too high for the Cadwell con-
QVM3 to function properly. vention

Low temperature. Shown when the ambient temperature is too low for the Cadwell con-
QVM3 to function properly. vention

Wait. Shown when the QVM3 first boots, and it's waiting for the system to Cadwell con-
stabilize before it can begin normal operation. vention

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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 Apollo+ 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

Revision and Configuration

The revision and configuration can be derived from the device serial numbers found on the
Apollo+ device label(s) as follows:

XXXXXX | XX | X | X | XX | XX | XXX

For example, the following serial number equates to Apollo+ 32 CH Amplifier (190301) REV 03

190301 | 03 | X | B | XX | XX | XXX

For example, the following serial number equates to Apollo 32 CH Amplifier (190301) REV 03

190301 | 03 | X | A | XX | XX | XXX

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Apollo+ Essential Performance

The Apollo+ amplifier inputs are type BF rated.

The batteries contained in the Cadwell Apollo+ Recorder do not require maintenance. No user
serviceable parts are contained in the Cadwell Apollo+ Recorder. Please contact Cadwell for
device service or replacement.

The Apollo+ 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 main-
tenance or service routines.

• The user can verify essential performance requirements using the test procedures and pass/
fail criteria outlined in Section 201.12.1.101 of IEC 60601-2-26:2012.
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 recorded with the pulse oximeter equipment and with a reference method. Accuracy
determined in accordance with ISO 80601-2-61, sub-clause 201.12.1.104.

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Maintenance Information
Factory Calibration

It is recommended to have Apollo+ EEG Systems calibrated annually. The Apollo+ system is cal-
ibrated at Cadwell Industries, Inc. No additional hardware calibration is needed.

Regular preventative maintenance never involves access to the interior of the Apollo+ system.
It involves regular inspection and cleaning of Apollo+ components.

Service Life
The expected service life of the Cadwell Apollo+ system, based on component mean-time-
between failure, is 10 years. The expected service life of the Cadwell Apollo+ Recorder batteries
is 300 charge cycles or up to 2 years. The expected service life of Cadwell Apollo+ cables is 1
year.

The expected service life of the Cadwell Q-Video Mobile 3 system, based on component mean-
time- between failure, is 10 years. The expected service life of the Cadwell Q-Video Mobile 3
batteries is 300 charge cycles or up to 2 years.

The expected service life of the Cadwell USB photic, based on component mean-time-between
failure, is 10 years.

The expected service life of Cadwell microphone and patient event button is 2 years.

Apollo+ Specifications and Operating Envir-

onment and Limits
Refer to Apollo+ Specification document 100871-931 for detailed specifications.

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Additional QVM3 Specifications

Mechanical
l Dimensions: 7.5"W x 3.2"D x 5.6"H (19.1cm x 8.1cm x 14.2cm)
l Weight: 2.7 lbs (1.22 kg)

Environmental Operating Limits

l Temperature: +10°C (+50°F) to +45°C (113°F)
l Relative humidity: 30% - 90% non-condensing
l Atmospheric pressure: 700 hPa to 1060 hPa

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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 mon-
itoring of patients.

MEDICAL ELECTRICAL EQUIPMENT complying with IEC 60601-1 such as Cadwell equipment and
accessories 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 elec-
trical 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,
uninterruptible 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 cir-
cuits powered from and grounded to the same electrical service entrance.

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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 connected 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-sys-
tem components as this can overload the transformer, or defeat the separation by provid-
ing 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 leak-
age current present in the patient environment.

DEFINITIONS
1. MEDICAL ELECTRICAL EQUIPMENT: Electrical equipment, provided with not more than
one connection 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.

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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 unin-
tentional 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 trans-
fer 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-outlets 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.

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Apollo+ Electromagnetic Emission and

Immunity to Electromagnetic Disturbances
This medical electrical equipment requires special precautions regarding Electromagnetic Com-
patibility (EMC) and needs to be installed and put into service according to the EMC inform-
ation 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 Cadwell as replacement parts, may result in increased emissions or decreased immunity
of the Apollo+ system.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Apollo+ system is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of the Apollo+ should assure that it is used in such an environment.
IEC 60601-1-2:2014
Emission Test Compliance Electromagnetic Environment Guidance
Radiated Emis- Class A The Apollo system complies with Class A when downloading
sions completed studies via USB cable. It is only suitable to download
CISPR 11 completed studies via USB cable within a professional health-
care environment.

Class B (all In all other modes of operation, including downloading com-

other modes) pleted studies wirelessly, the Apollo system complies with Class
B.
Conducted Emis- Class B The Apollo 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
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of
Apollo system, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
Radiated Emis- Class B Q-Video Mobile 3 is suitable for use in home healthcare environment
sions and professional heath care environment
Q-Video Mobile

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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

3 EN55032
Harmonic Dis- Complies Cadwell declares the Apollo+ system does not produce harmonic dis-
tortion IEC tortion emissions above established limits.
61000-3-2
Voltage fluc- Complies Cadwell declares the Apollo+ system does not produce voltage fluc-
tuations - flicker tuations or flicker emissions above established limits.
emissions IEC
61000-3-3
The Apollo+ system should not be stacked with any other equipment. If stacked use is neces-
sary, performance of the system should be observed to verify normal operation in the con-
figuration in which it will be used.
Guidance and Manufacturer’s Declaration – Electromagnetic Disturbances
The Apollo+ system is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of the Apollo+ 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 Apollo+ Sys-
charge. +/- 15 KV air tem. These noise glitches are easily differentiated
IEC 61000-4-2 from biopotential input signals. ESD noise is
unavoidable in high-static environments due to
the high input sensitivity 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 equip-
Fields IEC 610000- 80 MHz – 2.7 GHz ment should be used no closer to any part of the
4-3 Apollo+ System, including cables, than the recom-
mended separation distance calculated from the
equation applicable to the frequency of the trans-
mitter, 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 Apollo+
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 EFTs may cause events in the displayed wave-
Transients (EFT) PRF forms. This is an unavoidable phenomenon due
IEC 610000-4-4 AC mains -2KV, 100 KHZ to the high input sensitivity of the equipment.
PRF These waveform disturbances can be dif-

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Guidance and Manufacturer’s Declaration – Electromagnetic Disturbances

ferentiated from physiological events. To min-
imize these effects, mains power quality should
be that of a typical commercial or hospital envir-
onment.
Surge IEC 610000- +2KV, -2KV Line to Gnd Surges may cause events in the displayed wave-
4-5 forms. This is an unavoidable phenomenon due
to the high input sensitivity of the equipment.
These waveform disturbances can be dif-
ferentiated from physiological events. To min-
imize these effects, mains power quality should
be that of a typical commercial or hospital envir-
onment.
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
Immunity IEC cause events in the displayed waveforms. This is
610000-4-8 an unavoidable phenomenon due to the high
input sensitivity of the equipment. These wave-
form disturbances can be differentiated from
physiological events. To minimize these effects,
mains power quality should be that of a typical
commercial or hospital environment.
Voltage Dips IEC 0 % UT; 0.5 cycle g At 0°, Voltage dips may cause events in the displayed wave-
61000-4-11 45°, 90°, 135°, 180°, 225°, forms. This is an unavoidable phenomenon due to the
270° 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 gical events. To minimize these effects, mains power
quality should be that of a typical commercial or hos-
single phase at 0°
pital environment.
Voltage Inter- 0 % UT; 250/300 cycle For long interruptions the system maintains its
ruptions IEC functionality if the Apollo is powered from a
61000-4-11 laptop and the laptop battery is charged.

Table 1
Recommended separation distances between portable and mobile RF communications equipment

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and the Cadwell Apollo+

The Apollo+ 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 sep-
aration distance d in meters (m) can be estimated using the equation applicable to the fre-
quency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 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/ cord-
less) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Apollo+ system is used exceeds the applicable RF com-
pliance level of IEC 60601-1-2:2014, the Apollo+ 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.

Apollo+ Wireless Protocols and Specifications

Apollo+ RF Protocols and Specification
RF Protocol IEEE 802.11b/g/n (Device configured to operate at 2.4 GHz only)
Tx/Rx Frequency Range 2.412 GHz to 2.462 GHz (CH 1 to CH 11)
Data Rate 54 Mbit/s (OFMD)

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Apollo+ RF Protocols and Specification

Antenna type Fixed Internal Antenna. Antenna is not interchangeable
Antenna Gain 1.9 dBi
Tx Power (TI CC3100 Specification) 17 dBm, 1DSSS
17.25 dBm, 11CCK
13.5 dBm, 54 OFDM
Rx Sensitivity -94.7 dBm at 1 DSSS
-87 dBm at 11 CCK
-73 dBm at 54 OFDM

Operating Channels
In the US, the 2.4 GHz band is divided into 11 (14 in other parts of the world) channels spaced 5
MHz apart, beginning with channel 1 centered at 2.412 GHz and ending with channel 11
centered at 2.462 GHz. In addition, the 802.11 protocol requires that the Wi-Fi signal be atten-
uated a minimum of 20 dB from its peak amplitude at +/- 11 MHz from the center frequency.
Under these conditions the channel is effectively 22 MHz wide. The result of this requirements
is that only 3 channels, Ch1, Ch6, and Ch11 are nonoverlapping (see figure below) and are avail-
able to the user of the 802.11 protocol.
The Apollo+ system should not be used adjacent to or stacked with any other equipment. If
adjacent or stacked use is necessary, performance of the Apollo+ should be observed to verify
normal operation in the configuration in which it will be used.

Apollo+ Wifi module

Texas Instrument CC3100MODR1,FCC identifier: Z64-CC3100MODR1

Warning: Other equipment could interfere with the Apollo+ EEG System even if the other equip-
ment complies with applicable electromagnetic interference The requirements. The Apollo+ sys-
tem should not be used adjacent to or stacked with any other equipment. If adjacent or stacked
use is necessary, performance of the Apollo+ should be observed to verify normal operation in
the configuration in which it will be used. Use of Apollo+ EEG System with wireless capability
outside the US. Use outside the US may require regulatory approval from specific countries.

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Quality of Service and security recommended for use with Apollo+ wireless
Standard Wi-Fi service available in the home healthcare and professional healthcare envir-
onments with Wi-Fi Protected Access (WPA2).

Wireless performance
Apollo+ wireless system requires a file transfer rate of 1.5 Mbps or greater. During wireless com-
munication, the Apollo+ System verifies checksum for each data packet; packets with invalid
checksum are rejected. A gap in the EEG trace(s) indicates that data packets were rejected. Lost
wireless data can be retransmitted once wireless communication is recovered or by recon-
necting the USB cable.

Limitations
Wi-Fi communications is subject to interference and/ or loss of communication due to other
wireless transmitters operating at the same frequency or adjacent frequencies. When Wi-Fi
communication is lost, the system will display the following message: ”Recorder Disconnected”.

Compliance with wireless coexistence standards

Apollo+ System complies with wireless coexistence standards as described in the table below.
Wireless Standards for Coexistence Testing
Standard Description
ANSI C63.27:2017 Standard for Evaluation of Wireless Coexistence
AIM 7351731:2071 Immunity to RFID
FCC 15C Intentional Radiators
47 CFR1.1307(b) Specific Absorption Rate (SAR) Requirements

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Apollo+ Cleaning Instructions

Always disconnect all components from power before cleaning.

Perform cleaning and disinfection procedures on a per-use basis in compliance with your com-
pany infection control policy to ensure the safe operation of your Apollo+ 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 Apollo+ 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
Sterilization 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 Instru-
mentation at (703) 525-4890. www.aami.org

The Apollo+ amplifier and recorder, Photic Stimulator, Microphone, Patient Event Button, har-
ness, zippered pouch, and cables may be disinfected with an intermediate level surface dis-
infectant, but certain cleaning agents may have a degrading effect on your equipment. The
following list indicates cleaning products recommended by the plastic manufacturer as not caus-
ing 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

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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 electrical connectors. Do not let solutions seep inside the unit.

Disposal of Equipment
At the end of product life, please decontaminate the equipment before decommissioning.

Recycle Apollo+ batteries according to national and local regulations. Contact your local rep-
resentative for assistance. The batteries must be disposed only in a discharged state. In case of
not fully discharged batteries, provide for a method to reduce risk of short circuits. Short cir-
cuits can be prevented by isolating the battery terminals with insulating tape.

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 Inform-
ation that shipped with your system for details.

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For equipment warranty details and extended service package information, please see Cad-
well'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

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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 instru-
ment
[email protected]

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.
[email protected]

International Customers
Please contact your distributor directly or email at [email protected]

EU Importer
Cadwell Europe GmbH
Maximilianstr. 54
80538 Muchen, DE
[email protected]

Remote Assistance
Remote assistance and troubleshooting is available for systems under warranty or service con-
tract. With your permission, a support technician can establish a secure connection to your

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Cadwell instrument via the internet.

Please call the service department or application support department. A support or service tech-
nician will verify your account information and guide you through the steps to begin a remote
assistance session.

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