HeartCheck PEN Instruction Manual

The HeartCheck TM
Pen Device
Smart Monitoring
Powered by CardioComm Solutions, Inc.
(8) START: Press button to take a measurement.
(9) Left thumb Electrode.
(10) Left index finger Electrode.
(11) Battery cover.
(12) Clothing Clip.
Display Screen
The display screen shows the date and time, and battery icon. There are five menus
to navigate through use of the LEFT and RIGHT buttons as described below.

Menu Items

HR Measure: Select this screen, and press the START
button to start a recording.
HR Recordings: Select this screen to view recorded
measurements. Use the LEFT and RIGHT buttons to
navigate through recordings. Press POWER to replay
them (unlocked devices only).
Sys Setup: This menu allows you to set date, time, and
other settings.
Delete Data: This screen allows you to delete recorded
measurements. Use the LEFT and RIGHT buttons to
select a recording, and then press the POWER button to
delete it.
About: This screen provides device information such as
version and serial number.
Follow these six steps to properly measure and record your heart rhythm.

Step 1 - Preparation

Follow these instructions carefully for each device use. Failure to comply with any
of these instructions will result in an inaccurate measurement.
• If your skin is very dry, use a moisturizer.
• After each use, carefully disinfect the contact electrodes only with a
disinfectant swab or equivalent.

Step 2 - Take a Measurement

Hand Measurement
1. Press the POWER button to turn on the device.
2. Sit in a comfortable position, your back straight and keep your fingers and
arms in a relaxed position for full duration of the measurement.
3. Ensure the electrodes are in direct contact with your skin (fingers) as shown
with your left and right index fingers on the top electrodes, and your left and
right thumbs on the side electrodes.
4. Press the START button to begin a measurement.
5. The device will display a 6 second countdown, and then it will start the
recording.
6. During the 30 second recording, a heart will flash on the screen and a chime
will sound for each detected heart beat. A flashing clock icon indicates time
remaining in the recording. The screen will display a HR waveform if the
device is unlocked (refer to "Enable Heart Rhythm Display" below).
7. Remain still, and do not flex or move your fingers or arms until the 30 second
recording is complete. If the device senses poor contact or the measurement
is interrupted by a hand adjustment, you will need to repeat the recording.

Chest Measurement

If a hand measurement is not ideal, use the device to
take a chest measurement. Hold the device with your
right hand and place the other electrode against the
left side of your chest on bare skin about 5 cm (2 in)
about 5cm
below the left nipple.
CHEST MEASUREMENT FOR WOMEN
Position the device at the lower end of the breastbone
and move horizontally to the middle of the left part
of the chest. If necessary, lift the breast and place the
left end electrode under the left breast.
When complete, the result is displayed on the screen.

Step 3 - View the Measurement Analysis

After the measurement is complete, the device will display the heart rate, and a
finding of 'Stable Waveform' or 'Unexpected HR' . To save the measurement in the
device's memory, press the POWER button.
If you see Unexpected HR, repeat the preparation and measurement steps above.
If you have followed all measurement instructions in this guide, and continue to
receive "Unexpected HR" messages, consider consulting a physician or uploading
the recording through GEMS Home for an on-line medical review. The cause
TM
for an Unexpected HR may be a poor quality recording or the presence of a fast or
slow heart rate.
CAUTION!
The HeartCheck™ PEN device is not designed for medical diagnosis. Always
consult your physician if you notice any change in your health, regardless of the
measurement results. If you feel your medical condition has changed, consult a
physician even if "Stable Waveform" is displayed as the measurement result,
especially if you have been diagnosed with a prior heart condition.

Step 4 - Save the Measurement

After a measurement is complete, press the POWER button to save the recording.
Once saved the display will return to the Main Menu. The device will save up to 20
recordings, and will replace the oldest recordings with the newest if more than 20
records are attempted to be saved.

Step 5 - Review the Measurement Recordings

1. Select "HR Recordings" in the main menu screen, and press the POWER
button to enter.
2. Scroll through the records using the LEFT or RIGHT Button.
3. Press the POWER button to display the selected recording data.
Each recording contains the following information:
The recording number.
Number of recordings on the device.
Indicates a stable waveform recording.
Measured heart rate.
(bottom of display) Date and time of the recording.

Step 6 - Replay your Measurement Recordings *Unlocked devices only*

NOTE: Only unlocked HeartCheck PEN devices can replay Heart Rhythm
TM
waveforms (ECGs). If your device is locked, refer to "Enable Heart Rhythm
Display" below.
If your device is unlocked, follow these steps to replay the Heart Rhythm,.
1. Select the recording you wish to view, and press the POWER button.
2. The animated replay will pause after a moment. Scroll through the
remainder of the recording using the RIGHT and LEFT buttons. The
measurement contains 19 windows to scroll through, and the top left of
the display shows the window in view (eg: 01-02/19 is the first window).
3. To exit, press and hold the POWER button.
4. To adjust the speed of the replay; refer to "Other Settings".