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 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. 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.
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 depleted, the function of the Patient Activator changes. If the Patient Activator battery status is low or depleted contact Technical Support for a replacement Patient Activator. St. Jude Medical is focused on reducing risk by continuously finding new ways to put more control into the hands of those who save lives. 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 +1 818 364 5814 Fax +32 2 774 68 11 +1 651 482 8318 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