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

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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

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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)