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Patient Handbook
How to Record & Send Information
with your SJM Confirm™
Implantable Cardiac Monitor
The Patient Activator is part of the SJM Confirm™ Implantable Cardiac Monitor
(ICM). It is, in essence, a miniature external handheld computer. The Patient
Activator uses radio waves to communicate with your implanted device.
When placed over your implanted ICM, the Patient Activator signals the ICM
to begin recording the heart’s rhythm. It also can read the data that is stored
in the ICM and send that data to your physician over the telephone.
Step 1
Record Data
on command
You can use the Patient Activator
to record your heart’s electrical activity
on command.
Place the Patient Activator
over your device.
• The Patient Activator must be within
1.5 inches (4 cm) of your device.
Step 2
Press and release
the Record button
Recording is completed when the device
emits the Done signal (three high-pitched
beeps and yellow lights that flash for 9-10
seconds). You may then move the Patient
Activator away from your ICM.
• Recording takes less than 1 second.
REC
Record Data
on command
Step 3
READ DATA
Your clinician will let you know when
to read the recorded data from your
device using your Patient Activator.
• Do not move the Patient Activator until
it is done reading data.
• Reading data may take up to 2 minutes.
• If there is no data stored in your device and you
try to read data from your device, the Patient
Activator immediately emits the Done sound
(three high-pitched beeps) and you see flashing
yellow lights (for 9 to 10 seconds). There’s no
need to continue with the Send Data and the
Clear Data steps.
Read Data
Step 4
SEND DATA
Dial the telephone number for sending
the data, wait until a live person is on the
telephone with you before you send data.
• When your clinician tells you to do so, place the
telephone handset on a hard surface, such as a table.
Your clinician will give you a specific
telephone number to dial when you
send data, and he or she will tell you
how often you should send the stored data.
Send Data
• Place the back side of the Patient Activator near the
end of the telephone handset into which you talk.
The telephone handset and Patient Activator should
be no more than 1 inch (2.5 cm) apart. Depending on
the style of your telephone, you may need to adjust the
position of the telephone and Patient Activator.
• Press and release the Send button.
— Do not move the Patient Activator until sending data is done.
— Your clinician should tell you if the data was received.
— Sending data may take up to 5 minutes.
note: If your clinician tells you that you need to resend the data, press and release the Send button. Do not press and hold
the Send button, as this could clear the data. If you need to stop sending data, press and release the Send button.
All data stored in the Patient Activator must be sent to your clinician at one time. If you stop sending data before the
transmission is complete, you must resend all data again.
Step 5
Clear Data
Do not clear data from the Patient Activator
until your clinician tells you to do so.
• Press and hold the Send button for
a minimum of 5 seconds.
• You should not clear data from the Patient Activator
until you send data or attempt to send data.
Clear Data
note: If you accidentally clear the data from the Patient Activator before you successfully transmit the data
to your clinician, your clinician can access the data in your device in their office or clinic with the programmer.
If you cannot clear data and the Patient Activator emits the Incomplete sounds and lights up, there is data in
the Patient Activator that needs to be sent.
Patient Activator
Battery Status
As the Patient Activator battery becomes
St. Jude Medical is focused on reducing risk
depleted, the function of the Patient Activator
by continuously finding new ways to put more
changes. If the Patient Activator battery status
control into the hands of those who save lives.
is low or depleted contact Technical Support
for a replacement Patient Activator.
• Normal All sounds and lights are functional.
• Low One low-pitched beep and flashing red lights
for 9-10 seconds once every hour or immediately
when a button is pressed.
• Depleted The Patient Activator is silent
and there are no flashing lights.
Technical Support (customer service):
St. Jude Medical Cardiac Rhythm Management Division maintains 24-hour
phone lines for technical questions and product support.
note: For more information about your Patient Activator, please refer to the Patient Activator User’s Manual
and Quick Start Guide available from your clinician.
818.362.6822 USA 800.722.3774 TOLL FREE +46 8 474.4147 SWEDEN
ATRIAL FIBRILLATION
CARDIAC RHYTHM MANAGEMENT
CARDIAC SURGERY
CARDIOLOGY
NEUROMODULATION
St. Jude Medical
St. Jude Medical Sweden AB
St. Jude Medical Europe, Inc.
St. Jude Medical
Cardiac Rhythm Management Division
Veddestavägen 19
The Corporate Village
World Headquarters
15900 Valley View Court
175 84 Järfälla
Figueras Building
One Lillehei Plaza
Sylmar CA 91342
Sweden
Avenue Da Vinci Iaan, 11 Box F1
St Paul MN 55117
USA
+46 8 474 4000
B-1935 Zaventem
USA
+1 818 362 6822
+46 8 760 3855 Fax
Belgium
+1 651 483 2000
+32 2 774 68 11
+1 651 482 8318 Fax
+1 818 364 5814 Fax +32 2 772 83 84 Fax
www.sjm.com/confirm
CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Consult the User’s Manual for information on indications, contraindications, warnings and precautions. Unless otherwise noted, ® or ™
indicates that the name is a trademark of, or licensed to, St. Jude Medical, or one of its subsidiaries.
© 2008 St. Jude Medical. All rights reserved.
Item No. 100003784 Printed in the US 082508