TZ Medical Clarus 40L User manual

Clarus 40L
Mobile Cardiac Monitor
Operator Manual

Revision 1.10 Document No. 17102 Page 2
Contents
Device Overview........................................................................................................................................................4
Description .......................................................................................................................................................................... 4
Indications for Use .............................................................................................................................................................. 5
Contraindications ................................................................................................................................................................ 5
Recorder Components ........................................................................................................................................................ 6
Equipment Symbols ............................................................................................................................................................ 7
Precautions ......................................................................................................................................................................... 8
Operation ..................................................................................................................................................................9
Initial Device Setup.............................................................................................................................................................. 9
Power on the Device ........................................................................................................................................................... 9
User Interface.................................................................................................................................................................... 10
Network Status.................................................................................................................................................................. 11
Shutting Off ....................................................................................................................................................................... 12
Adjusting the Settings ....................................................................................................................................................... 13
Starting a Study ................................................................................................................................................................. 15
Electrode Application........................................................................................................................................................ 17
Marking an Event .............................................................................................................................................................. 18
Monitoring a Study ........................................................................................................................................................... 20
Receiving Messages .......................................................................................................................................................... 21
Ending a Study................................................................................................................................................................... 22
Removing Patient Data ..................................................................................................................................................... 23
Patient Use Precautions .................................................................................................................................................... 24
Patient Responsibilities..................................................................................................................................................... 24
Maintenance ...........................................................................................................................................................25
Charging ............................................................................................................................................................................ 25
Storage .............................................................................................................................................................................. 26
Cleaning............................................................................................................................................................................. 26
Testing............................................................................................................................................................................... 26
Troubleshooting ......................................................................................................................................................27
Error Messages.................................................................................................................................................................. 27
Specifications...........................................................................................................................................................28
TZ Medical Warranty................................................................................................................................................31
Limited Warranty .............................................................................................................................................................. 31
Obtaining Warranty Service .............................................................................................................................................. 31
Accessories..............................................................................................................................................................32

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Wireless Compliance................................................................................................................................................33
EMC Precautions......................................................................................................................................................35

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Device Overview
Description
Caution: US Federal law restricts this device to sale by or on the order of a physician.
The Clarus 40L is a battery operated ambulatory electrocardiograph recorder for use in mobile cardiovascular telemetry.
It is capable of storing up to 4 channels of patient ECG data acquired from surface electrodes adhered to the body for up
to 30 days of continuous recording. The Clarus 40L employs a rechargeable lithium polymer battery to achieve such an
extended recording duration.
The Clarus 40L provides the ability to automatically detect and record pacemaker pulses as well as several common
arrhythmias in accordance with the applicable standards of the International Electrotechnical Commission (IEC).
The Clarus 40L 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 Clarus 40L 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 Clarus 40L does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the
responsibilities of a trained healthcare professional or physician.

Revision 1.10 Document No. 17102 Page 5
Device Overview
Indications for Use
The Clarus 40L is intended for use by individuals who are at risk of having cardiac disease and those that have
intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis.
The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF
Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare
professional.
Patients include, but at are not limited to, those requiring monitoring for
a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS,
PSVT) and ventricular ectopy,
b) evaluation of brady-arrhythmias and intermittent bundle branch block including after cardiovascular surgery
and myocardial infarction, and
c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
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.
Patients with symptoms that may be due to cardiac arrhythmias.
These may include, but are not limited to, symptoms such as
a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded,
b) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain
correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial
fibrillation). Patients recovering from cardiac surgery who 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 Clarus 40L is not intended for use under the following conditions:
Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Patients who the attending physician thinks should be hospitalized.
NOTE: The Clarus 40L does not provide interpretive or diagnostic statements. Interpretation and diagnosis is the
responsibility of a trained healthcare professional or physician.

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Device Overview
Recorder Components
Figure
1
1. Accessory Cable
Connector/Charging
port
2. Color Touchscreen
3. Power Button
Front view of the Clarus 40L.
Figure 2
4. Serial Number
Back view of the Clarus 40L.
1
4
2
3

Revision 1.10 Document No. 17102 Page 7
Device Overview
Equipment Symbols
Consult the Directions for Use
Type BF device
Electrically Isolated
Manufacturer
Info
Rx Only Prescription Only
IP22 Device has ingress rating of IP22 in accordance
with IEC 60529
Recycling Symbol - Do not dispose of this product
as unsorted municipal waste. Prepare this product
for reuse or separate collection as specified by
Directive 2002/96/EC of the European Parliament
and the Council of the European Union on Waste
Electronic and Electrical Equipment (WEEE). If this
product is contaminated, this directive does not
apply.

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Device Overview
Precautions
Use only cables provided by TZ Medical with the Clarus 40L.
Disconnect patient leads before defibrillation.
To reduce the risks of strangulation or asphyxiation do not leave electrode cables accessible to infants or
children. Carefully route the electrode cables to reduce the possibility of entanglement or strangulation
during use.
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 achieve 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).
Do not allow conductive parts of the Clarus 40L patient electrodes to contact other conductive parts
including earth.
Allow 2 hours for the Clarus 40L to warm from the minimum storage temperature or to cool from the
maximum storage temperature before operating the device.
The Clarus 40L device should only be connected to a PC certified to IEC 60950-1 when using the USB Cable
(PN: H3R-0025).
Changes or modifications made to this equipment not expressly approved by TZ Medical may void the FCC
authorization to operate this equipment.
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

Revision 1.10 Document No. 17102 Page 9
Operation
Initial Device Setup
The Clarus 40L is delivered ready for use. Please consult with your software provider to determine if any additional
configuration is required for your specific use case.
Power on the Device
To power on the Clarus 40L, hold down the circular power button, as shown in Fig. 1, for at least one second. After
approximately three seconds, the Clarus 40L will vibrate and the screen will light up displaying the Starting Up screen
provided in Fig. 3. The Starting Up screen will last approximately five seconds before the device automatically redirects
itself to the Welcome display, as shown in Fig. 4.
Figure 3
The Starting Up screen that is displayed
when powering on the Clarus 40L.

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Operation
User Interface
The Clarus 40L employs a graphical user interface consisting of a color touchscreen for configuration and patient hookup
procedures. The menus on the device can be navigated by gently touching and releasing the graphical buttons on the
display.
Figure
4
The welcome screen is displayed on startup.
The status bar found at the top of the display on the Clarus 40L displays a user-configurable message, the battery status,
number of pending uploads (discussed in more detail on page 10), and the network status (discussed in more detail on
page 10).
Press the power icon to power off the device, press the gear icon to adjust the device’s settings, or press the plus icon to
start a new study. If the patient ID setting has been set to a value other than 0, the bottom bar will display this value.
Otherwise, the bottom bar will display the current firmware version of the device.
Figure 5 Figure 6 Figure 7
Power Icon (Shut Off) Plus Icon (New Study) Gear Icon (Settings)

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Operation
Network Status
The network status is always displayed in the upper left-hand corner of the screen. The number of pending
transmissions counts up to 99, and a blue antenna icon is shown when the device is connected to the network. The
device will periodically turn off its modem to save power. In this case, no icon will be displayed next to the pending
transmission count. It will also display a dash icon when searching for a network or a red antenna icon if it gets rejected
by the network.
Figure
8
Figure
9
The device has 7 pending
transmissions, and it is searching for a
network to which it can connect.
The device is connected to a network
and currently uploading 7 pending
transmissions.
Figure 10 Figure 11
The device’s request to connect was
rejected by the network, but it still has
7 pending transmissions.
The device
is not connected to any
network or searching, but it has 7
pending transmissions.

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Operation
Shutting Off
There are two ways to turn off the Clarus 40L:
1) Start by pressing the power icon, provided in Fig. 5, on the Welcome screen. The device will be automatically
redirected to a display as shown in Fig. 12. To confirm the shutdown press the power icon in the middle of the
screen.
Figure 12
Confirm the shutdown command by touching the
power icon again.
2) Alternately, the device may be powered off at any time by pressing and holding the power button for
approximately five seconds or until the display shuts off. This latter method is not preferred.

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Operation
Adjusting the Settings
Figure
13
After pressing the gear icon (settings button) provided in Fig. 7 on the
Welcome screen, the device will automatically be directed to the first
page of the settings menu with the display provided in Fig. 13. While
on this screen, pressing the bottom-left arrow button will redirect the
device back to the Welcome screen. Pressing the bottom-right arrow
button will allow the user to navigate forward to the second page of
the settings menu with the display shown in Fig. 14.
First page of the settings menu.
Figure 14
The second page of the settings menu allows the user to change the
Study Length, Wireless Holter, and MCT Mode settings of the device by
touching the respective white box. While on the second page of the
settings menu, pressing the bottom-left arrow button will redirect the
device back to the first page of the settings menu, while pressing the
bottom-right arrow button will allow the user to navigate forward to
the third page of the settings menu with the display shown in Fig. 17.
Study Length: Changes study length duration.
Wireless Holter: Uploads information through a network.
MCT Mode: Transmits trend information to be billed as MCT.
The second page of the settings menu.
Figure 15
If the user touches the white box respective to the Study Length
setting, the display shown in Fig. 15 will show on the device screen.
Pressing the X button will result in returning to its previous study
length setting, as well as returning to the second page of the settings
menu.
NOTE: The check cannot be pressed until a number has been input.
Display previous to setting study length.

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Operation
Adjusting the Settings (continued)
Figure 16
The check will light up as shown in Fig. 16 after a study length number
has been input. After the correct study length has been input, press
the check in order to save the new study length and return to the
second page of the settings menu. Pressing the X button will result in
returning to its previous study length setting, as well as returning to
the second page of the settings menu.
NOTE: Other number input settings (Current Time, Current Date, PIN
Code) can be completed through the same steps provided for Study
Length.
Display after setting study length.
Figure 17
The third page of the settings menu allows the user to change the
Current Time, Current Date, and Pacer Detection settings of the device
by touching the respective white box. While on the third page of the
settings menu, pressing the bottom-left arrow button will redirect the
device back to the second page of the settings menu, while pressing
the bottom-right arrow button will allow the user to navigate forward
to the fourth (final) page of the settings menu with the display shown
in Fig. 18.
Current Time: Current time (military time; 0-24 hours)
Current Date: Current date (YYYY-MM-DD)
Pacer Detection: Device creates a mark in ECG record when a
pacemaker pulse is detected.
The third page of the settings menu.
Figure 18
The final page of the settings menu allows the user to view the Device
Information and set a PIN Code for the device by touching the
respective white box. While on the final page of the settings menu,
pressing the bottom-left arrow button will redirect the device back to
the third page of the settings menu, while pressing the bottom-right
arrow button will allow the user to navigate back to the Welcome
screen.
Device Info: Provides device information.
PIN Code: Input a PIN Code for a patient.
The fourth (final) page of the settings menu.

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Operation
Starting a Study
To start a study, press the plus icon provided in Fig. 6 on the Welcome screen. The device will be directed to a screen
with a display similar to Fig. 19 or Fig. 20. On this screen, confirm the start of the study by pressing the plus icon in the
center of the screen. To return back to the Welcome screen, press the bottom-left arrow button. The length of the study
that was manually added within the settings will be displayed under the “Duration” text as shown in Fig. 19 and Fig. 20.
The remaining battery life of the Clarus 40L will be displayed under the “Battery” text as shown in Fig. 19 and Fig. 20.
Figure 19
Figure 20
Figure 21
This device is ready to start a new
study.
The battery will have to be recharged
during the study.
The PIN Code screen.
If the PIN Code setting was set to a value other than 0 while setting up the settings, the device will prompt the patient to
enter the PIN Code as provided in Fig. 21. This is generally used when the patient is not present when the device is
configured. If this is the case, the device can be powered down for shipment by pressing and holding the power button
until the screen turns off. When the patient receives the device, they can power it on by pressing and holding the power
button for at least 1 second. After the device boots, they can follow the on-screen instructions to enter the correct PIN.
The PIN should be provided separately to the patient.

Revision 1.10 Document No. 17102 Page 16
Operation
Starting a Study (continued)
After the patient has pressed the check mark provided in Fig. 21 the user will then be able to enter their PIN Code which
should be provided by their physician. In Fig. 22 it is noticed that the user cannot press the check mark until a number is
input. Once a number has been put in, the check mark becomes visible as shown in Fig. 23. If the PIN Code is input
incorrectly, or if the user presses the X button, the device will be redirected back to the Patient Verification screen
provided in Fig. 21, the patient can then go through the same steps in order to input the correct PIN Code.
Figure 22 Figure 23
Display previous to patient inputting PIN Code. Display after patient inputs PIN Code.
After the PIN has been entered correctly (or if the PIN Code setting was set to 0), the display in Fig. 24 will be presented
on the screen, indicating that the device is ready to monitor, prompting the patient to connect the patient cable to the
device. It is recommended that the patient connect all electrodes prior to connecting the cable to the device, as the
device will launch a signal quality screen displaying tracings from all channels supported by the cable, as shown in Fig.
25. The legend at the bottom of the screen may be used to identify which electrode, if any, needs correction.
Figure 24 Figure 25
Ready to monitor. Signal quality can be evaluated on this screen.

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Operation
Electrode Application
Employ the following procedure when applying electrodes to a patient and connecting them to the Clarus 40L:
1. Select electrode sites to match the configured electrode configuration shown in the following figures or as
instructed by the physician. Select areas over bone, avoiding muscle areas and breast tissue.
2. Clean electrode sites with alcohol and use a razor to remove hair.
3. Abrade electrode sites with a scrub pad or gauze. Allow sites to dry before applying electrodes.
4. Connect the patient lead wire to the electrode snap.
5. Remove the protective backing from the electrode.
6. Apply the electrode to the patient’s skin, pressing the border firmly to ensure consistent adhesion. Make sure to
match electrodes to the selected configuration from the following figures or as instructed by the physician.
7. To alleviate tension on electrode snaps, loop patient lead wires and tape down.
NOTE: When plugging cable into device, cord faces up (away from patient). The cable might need some force to be
completely inserted.
Figure
26
Figure
27
Figure
28
3-electrode (H3R-0017) hookup. 4-electrode (H3R-0077) hookup. 5-electrode (H3R-0019) hookup.
Electrode Color Application Placement Configuration
Black LA 3-electrode; 4-electrode; 5-electrode
White RA 3-electrode; 4-electrode; 5-electrode
Red
LL
3
-
electrode; 4
-
electrode; 5
-
electrode
Green RL 4-electrode; 5-electrode
Brown V5 5-electrode

Revision 1.10 Document No. 17102 Page 18
Operation
Marking an Event
Figure
29
Once a study has been started, the Clarus 40L will silently
record ECG data with no intervention from the patient.
The patient can wake the display provided in Fig. 29 by
briefly pressing the power button. This display allows the
user to view the time remaining for the study as well as
instructions on how to mark an event. After pressing the
plus button, the display shown in Fig. 30 will be displayed
on the screen.
NOTE: If the user does not touch the plus button or
power button for approximately 20 seconds, the device
screen will go back to sleep.
Study
progress and event instructions.
Figure 30
Pressing the bottom-left arrow will bring the user back to
the previous screen displayed in Fig. 29. Pressing the
lower-right arrow will bring the user to the Symptom
Diary screen displayed in Fig. 31.
First page of marking an event.
Figure 31
Use the up and down arrows to scroll through the
symptoms list in order to place the correct symptom into
the white box. While on the Symptom Diary screen,
pressing the bottom-left arrow button will redirect the
device back to the first page of the marking an even
menu, while pressing the bottom-right arrow button will
allow the user to navigate forward to the third page of
the marking an event menu with the display shown in Fig.
32.
NOTE: The scroll cannot be used to go up and down the
list, it merely provides a visual for where you are in
regards to the list view.
Second page (Symptom Diary page) of marking an event.

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Operation
Marking an Event (continued)
Figure 32
Pressing the bottom-left arrow will bring the user back to
the previous Symptom diary screen displayed in Fig. 31.
Pressing the lower-right arrow will bring the user to the
Activity Diary screen displayed in Fig. 33.
Third page of marking an even.
Figure 33
Use the up and down arrows to scroll through the activity
list in order to place the correct activity into the white
box. While on the Activity Diary screen, pressing the
bottom-left arrow button will redirect the device back to
the third page of the marking an even menu, while
pressing the bottom-right arrow button will allow the
user to navigate forward to the event confirmation page
with a display provided in Fig. 34.
NOTE: The scroll cannot be used to go up and down the
list, it merely provides a visual for where you are in
regards to the list view.
Fourth page (Activity Diary page) for marking an event.
Figure 34
This page shows the user what Symptom and Activity
were chosen for the event, allowing them to change if
necessary. To change the symptom or activity, the user
would need to hit the bottom-left arrow until the correct
diary is displayed, in which they would need to select the
correct text from the list provided, as explained
previously. If the symptom and activity is correct, then
the user can confirm the event by touching the plus
button.
Event confirmation page.

Revision 1.10 Document No. 17102 Page 20
Operation
Marking an Event (continued)
Once an event has been successfully marked, the display provided in Fig. 35 will be displayed on the screen and will
vibrate for approximately three seconds. After those three seconds, the device will be redirected to the monitoring
screen display provided in Fig. 29.
Figure
35
Event confirmation page.
Monitoring a Study
If electrodes become disconnected during the course of a study, the device will notify the patient by vibrating and by
displaying a message on the screen indicating the correct location of each electrode. The hookup diagram is keyed to the
patient cable such that the proper diagram is always displayed, regardless of which patient cable is used. Disconnecting
the patient cable from the recorder will stop the recording, should the patient need to remove the electrodes for some
reason. The Clarus 40L will continue to record as long as the patient cable is connected, regardless of electrode status.
Figure 36 Figure 37
An electrode has been disconnected. The patient cable has been disconnected.