TZ Medical Aera CT 3G User manual

Revision 1.2
Document No. 14480
Page 1
Aera CT 3G
Mobile Cardiac Monitor
Operator Manual

Revision 1.2
Document No. 14480
Page 2
Contents
Device Overview........................................................................................................................................................3
Description.......................................................................................................................................................................... 3
Indications for Use .............................................................................................................................................................. 4
Contraindications................................................................................................................................................................ 4
Recorder Components ........................................................................................................................................................ 5
Equipment Symbols ............................................................................................................................................................ 7
Precautions ......................................................................................................................................................................... 8
Operation ..................................................................................................................................................................9
Battery Installation Instructions.......................................................................................................................................... 9
Initial Device Setup ........................................................................................................................................................... 10
User Interface ................................................................................................................................................................... 11
Starting a Study................................................................................................................................................................. 12
Monitoring a Study ........................................................................................................................................................... 17
Ending a Study................................................................................................................................................................... 19
Electrode Application........................................................................................................................................................ 22
Patient Use Precautions.................................................................................................................................................... 24
Maintenance ...........................................................................................................................................................25
Charging ............................................................................................................................................................................ 25
Storage .............................................................................................................................................................................. 25
Cleaning............................................................................................................................................................................. 26
Testing............................................................................................................................................................................... 26
Troubleshooting ......................................................................................................................................................27
Error Messages.................................................................................................................................................................. 27
Server Errors ..................................................................................................................................................................... 28
Wireless Compliance................................................................................................................................................29
Specifications...........................................................................................................................................................30
TZ Medical Warranty................................................................................................................................................32
Limited Warranty .............................................................................................................................................................. 32
Obtaining Warranty Service.............................................................................................................................................. 32
Accessories ..............................................................................................................................................................33

Revision 1.2
Document No. 14480
Page 3
Device Overview
Description
Caution: US Federal law restricts this device to sale by or on the order of a physician.
The Aera CT is a battery operated ambulatory electrocardiograph recorder for use in mobile cardiovascular
telemetry. It is capable of storing 3 channels of patient ECG data acquired from three or five surface electrodes
adhered to the body for over 28 days of continuous recording. The Aera CT employs a rechargeable Lithium-
Ion battery to achieve such an extended recording duration.
The Aera CT provides the ability to automatically detect and record pacemaker pulses as well as several
common arrhythmias in accordance with the applicable standards of the Association for the Advancement of
Medical Instrumentation (AAMI).
The Aera CT contains an internal cellular modem to allow access to the patient ECG data and analysis results.
Any piece of data recorded on the device may be queried wirelessly during the course of the study. Additionally,
data transmissions may be triggered automatically or manually as a result of arrhythmia analysis, or manual
patient input, respectively.
The Aera CT provides a multitude of options to control recording parameters such as bit resolution, sampling
rate, and frequency response as well as analysis parameters such as heart rate thresholds. These settings may
be updated wirelessly during the course of a study to allow the device to dynamically adapt to the needs of the
operator.
The Aera CT does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the
responsibilities of a trained healthcare professional or physician.

Revision 1.2
Document No. 14480
Page 4
Device Overview
Indications for Use
The Aera CT is intended for acquiring ambulatory ECG signals from patients who either are at risk of
having cardiac disease or have intermittent symptoms indicative of cardiac disease and who have
demonstrated a need to be monitored on a continuing basis.
Indications for conducting ambulatory recording include:
Patients requiring monitoring for non life-threatening arrhythmias such as supraventricular
tachycardias and ventricular ectopy.
Patients requiring monitoring for evaluation of bradyarrhythmias and intermittent bundle
branch block including after cardiovascular surgery and myocardial infarction.
Patients requiring monitoring for arrhythmias associated with co-morbid conditions such as
hyperthyroidism or chronic lung disease.
Patients experiencing symptoms such as a) syncope of unknown etiology or b) shortness of
breath which may be due to cardiac arrhythmias.
Patients with palpitations with or without known arrhythmias to obtain correlation of
arrhythmias with symptoms.
Patients who require monitoring of the effects of drugs to control ventricular rate in atrial
arrhythmias.
Patients recovering from cardiac surgery that are indicated for outpatient arrhythmia
monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central)
to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia,
possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze, measure, or report QT interval. The
device is not intended to sound any alarms for QT interval changes.
Contraindications
The Aera CT is not intended for use under the following conditions:
Infants weighing less than 10 kg. (22 lbs.).
Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Patients who the attending physician thinks should be hospitalized.

Revision 1.2
Document No. 14480
Page 5
Device Overview
Recorder Components
Figure 1
1. Color Display
2. Patient Event Button
3. Up Key
4. Left Key
5. Select Key
6. Right Key
7. Down Key
Front view of the Aera CT.
Figure 2
1. Battery
Compartment
2. microSD Card
Holder
3. Serial Number
Back view of the Aera CT.
1
2
3
4
5
6
7
1
2
3

Revision 1.2
Document No. 14480
Page 6
Device Overview
Recorder Components (continued)
Figure 3
1. Patient Cable Receptacle
2. Power Cable Receptacle
3. Power Receptacle Plug
Side view of the Aera CT.
1
2
3

Revision 1.2
Document No. 14480
Page 7
Device Overview
Equipment Symbols
Consult the
Directions For Use
Type B device
Electrically
Isolated
Manufacturer
Info
Emits Non-ionizing
Radiation
RX Only
Prescription Only

Revision 1.2
Document No. 14480
Page 8
Device Overview
Precautions
Use only a TZ Medical, Inc. certified microSD memory card for recording.
Do not connect anything other than the battery charger provided by TZ Medical, Inc. to the charge
port on the Aera CT.
Use only patient cables provided by TZ Medical, Inc. with the Aera CT.
Observe the procedures for early recording cessation. Failure to do so may result in the loss of
recorded data. (Page 17)
Disconnect patient leads before defibrillation.
False positive and false negative pacer pulse detects may occur when using Pacemaker Pulse
Detection.
False positives –may result from poor electrode connection to the patient or a large amount
of electrical interference from nearby source.
False negatives –may occur with pacemakers that are bipolar because of a weak pacemaker
pulse signal at the patient’s skin.
When viewing the ECG data, the presence of pacemaker signals in the ECG trace should not be
considered true representations of the actual pacemaker stimulus amplitude.
To avoid unintended battery discharge, do not leave the battery in the recorder when it is not in use.
To receive the best recording results, instruct patients to stay away from heavy electrical equipment
or other sources of electromagnetic interference. This includes equipment such as electric blankets
and heating pads.
Avoid exposing device to water or excessive moisture.
Do not expose device to extreme temperatures (beyond the limits shown in the environmental
specifications).

Revision 1.2
Document No. 14480
Page 9
Operation
Battery Installation Instructions
1. Align slots in battery with tabs in device.
2. Push battery down on side opposite the tabs.
Figure 4
Battery Insertion.

Revision 1.2
Document No. 14480
Page 10
Operation
Initial Device Setup
When you first receive your Aera CT device, the wireless system must be configured to communicate with your
receiving software. To achieve this, follow the instructions from your software provider to load the necessary
wireless settings onto the provided microSD card.
Insert the configured microSD card into the card holder, located in the battery compartment, of the Aera CT.
Insert the battery and replace the battery cover.
On power-up, the Aera CT will detect the wireless settings and attempt to connect to the new server to verify
the new settings. This process may take a few moments to complete.
Figure 5
This screen will be displayed while the
Aera CT is verifying new wireless settings.
Once the Aera CT has successfully connected to the new server, it will store the wireless settings internally for
future use. The device will then delete all settings from the microSD card for security purposes and begin
normal operation.
If the Aera CT cannot connect to the server using the settings provided on the microSD card, it will display an
error message on the screen. The Aera CT will not function properly until it has been successfully configured
with valid wireless settings.

Revision 1.2
Document No. 14480
Page 11
Operation
User Interface
The Aera CT employs a graphical user interface consisting of a color LCD and 5 touch-sensitive keys for
configuration and patient hookup procedures. The only touch-sensitive areas of the device are the 5 keys. The
LCD is NOT a touch screen.
Note: Aggressive attempts to use the LCD as a touch-screen can result in irreparable damage
to the LCD.
The 5 keys are arranged in the shape of a plus sign (+) with a blue light in the center of each key. (See Fig. 1)
The center key is the select key, and the 4 surrounding keys are the directional keys, which can be used to
scroll left, right, up, and down.
The keys can be used by lightly touching and then releasing the blue light. Each key must be released before
any additional key may be pressed. This helps protect against accidental selections. The keys will only be lit
when they are usable. There may be times where none, or only some, of the keys are functional.
To interact with the Aera CT menu system, choose an on-screen element using the directional keys and then
select it with the center, select key. The currently selected icon on the screen will always be highlighted, while
all non-selected elements will be dimmed. (See Figs. 4 and 5)
Figure 6
Figure 7
On this screen, the Power Off
element is currently selected.
On this screen, the New Study
element is currently selected.
The status bar found at the top of the display on the Aera CT displays information about cellular connectivity,
battery life, and the current date and time. On the Aera CT, the date is always displayed in the format year-
month-day (yyyy-mm-dd). The time is always displayed as a 24-hour clock in the format hours:minutes
(hh:mm).

Revision 1.2
Document No. 14480
Page 12
Operation
Starting a Study
To begin a new patient study, the receiving software must first be configured. Follow the instructions from your
software provider to set all of the relevant parameters and prepare the server for the new patient study. If it is
anticipated that the patient hookup procedure will be performed in a location that does not have reliable
wireless connectivity, this process should include loading the settings for the study onto the microSD card in
the device, according to the instructions from your software provider.
Once the server has been properly configured, the Aera CT device may be synchronized with the server.
Begin by powering on the device by inserting the Lithium-Ion battery into the battery compartment. Upon
power-up, you should see one of two screens: a screen indicating that a recording has been completed or a
screen indicating that a recording has not yet been configured. Both of these screens provide options to either
power off the device or to start a new study.
Note: If the screen indicates that the Aera CT is recording, or attempting to record data, the
current study must be ended before a new study may be configured.
Figure 8
Figure 9
This device has old data in its memory
that must first be erased.
This device has no old data in its memory
and is ready to start a new study.
Once the Aera CT has been powered up, select the NEW STUDY option to begin the new study process. If
there is still data present on the microSD card from a previous study, you will be prompted to erase the data
before continuing.
In order to erase the microSD card from the user interface, you will be required to enter a security code. This
code is the first 4 digits of the device’s serial number. After entering the code, you will be asked one more time
if you are sure you want to erase the data.
Select ERASE to continue.

Revision 1.2
Document No. 14480
Page 13
Operation
Starting a Study (continued)
Figure 10
Figure 11
This device needs to erase the SD card
before it can continue with a new study.
The device will double check to make sure
that you want to erase all the data.
When there is no data on the microSD card, you will be prompted to update the device’s clock. See User
Interface section on pg. 8 for information on the display format for date and time. If a network connection is
available, the time should be automatically updated. If a network connection is not available, it may be
necessary to manually update the data and time using prompts on the device.
To Set the Time and Date Manually:
Select the ADJUST DATE/TIME MANUALLY option and follow the on-screen instructions to update the
device clock. Once the device is displaying the proper date and time, select the SAVE option to continue.
Figure 12
Figure 13
The device will prompt you to check that
the device time is correct.
Use this page to manually enter the time
when the network is unavailable.

Revision 1.2
Document No. 14480
Page 14
Operation
Starting a Study (continued)
Once the device time has been verified, the Aera CT must load the proper settings for the new study.
If the settings were previously loaded onto the microSD card, select the KEEP CURRENT option to continue.
This could be used when poor wireless reception is expected.
If you wish to have the settings updated, select the UPDATE option to connect to the server and download the
latest device settings.
Note: If the server has not been properly configured, or if wireless reception is poor, selecting
UPDATE will result in an error message.
Figure 14
Figure 15
This device needs to download the settings
for the study to continue.
This device has been loaded with settings
prior to this setup procedure.

Revision 1.2
Document No. 14480
Page 15
Operation
Starting a Study (continued)
Once the device has successfully downloaded the latest settings, it will automatically prompt you to connect the
patient to the device by displaying the selected electrode configuration on the display. It will also silently report
the successful settings download action to the server in the background.
Apply the electrodes to the patient and connect the patient cable to the device.
Note: if the Aera CT has been configured for use with a 3-electrode cable, it will not work with
a 5-electrode cable and vice-versa. If an error message appears and indicates that you are
using the wrong patient cable, you must either change the configuration on the server and
update the settings on the device or switch to a compatible patient cable.
Once all of the electrodes have been connected, the Aera CT will automatically proceed to the signal quality
check screen. If necessary, select the NEXT option to manually proceed to the signal quality check.
Figure 16
Figure 17
This device has been configured to
use a 5-electrode patient cable.
This device has been configured
to use a 3-electrode patient cable.

Revision 1.2
Document No. 14480
Page 16
Operation
Starting a Study (continued)
On the “ECG Quality” screen, the Aera CT will draw the ECG trace from one of its three input channels in real
time.
Toggle which channel is being drawn by highlighting the LEAD option and pressing SELECT. If necessary,
highlight the SCALE option and press SELECT to change the dynamic range of the display. Once all three
channels are showing acceptable ECG traces, select the right-arrow icon to continue.
Note: changing the scale here is for previewing purposes only; it does change the scale of the recording.
Figure 18
A typical ECG signal as seen
during the hookup procedure.
Once the signal quality has been verified, the Aera CT will display the message DEVICE READY, and prompt
you to begin the study. Select the BEGIN STUDY option to start the recording. As soon as this option is
pressed, the Aera CT will begin recording and analyzing ECG data. After successfully recording the first 60
seconds of data, the device will silently report that the recording has started, and send the first minute of data
to the server.
Figure 19
The last screen before the study begins.

Revision 1.2
Document No. 14480
Page 17
Operation
Monitoring a Study
Once a study has been started, the Aera CT will silently record and transmit ECG data with no intervention
from the patient. The patient can wake the display by briefly pressing the patient event button to view a status
screen with instructions on how to mark an event.
If enough of the patient electrodes are disconnected so that the Aera CT cannot continue recording ECG on any
channel, the device will automatically wake the display and show a message to the patient instructing him or
her to reconnect the patient cable.
The bottom 2 lines of text on these screens may be programmed to display the name and phone number of the
monitoring center. Follow the instructions from your software provider to change this text.
Figure 20
Figure 21
The device is currently recording and
analyzing ECG data from the patient.
The device has stopped recording ECG
data because the leads are disconnected.

Revision 1.2
Document No. 14480
Page 18
Operation
Monitoring a Study (continued)
For the duration of the study, the Aera CT will periodically upload files to the receiving server. These event files
provide information on the status of the device, (such as battery life, recording state, and electrode connection
status), as well as information on detected arrhythmias and patient activated events. Follow the instructions
from your software provider to monitor the server for these event files.
The Aera CT also provides the means to request specific data from the device and to send messages in plain text
to the patient. In the event that the device’s operating settings need to be adjusted to reduce the amount of data
being reported to the server, the Aera CT provides the tools to wirelessly download new settings from the
server. Follow the instructions from your software provider to access this functionality.
Figure 22
A text message being displayed to the
patient on the Aera CT’s screen.

Revision 1.2
Document No. 14480
Page 19
Operation
Ending a Study
The Aera CT provides 2 automated methods and 2 manual methods for ending a study. When the Aera CT is
configured at the beginning of the study, it can be programmed to automatically end the study after a specific
length of data has been recorded, or to end the study at a specific date and time. Follow your software
provider’s instructions to control the Aera CT with these parameters. When either of these preconfigured
stopping points is reached, the Aera CT will stop the study and report the completion to the server.
When the study is ended by reaching a preconfigured stopping point, the Aera CT will wake the display and
report to the patient that the study is complete. If necessary, the study may be resumed by simply adjusting the
study end parameters and performing a wireless settings update.
Figure 23
The patient will be notified
once the study is complete.
The Aera CT can also be wirelessly instructed by the server to end the study immediately. If this method is used
to end the study, the device cannot be instructed to resume recording; a new study will have to be configured
and started as before.