St. Jude Medical SJM Confirm DM2100A User manual

SJM Confirm™
Model DM2100A
External Patient Activator
User’s Manual

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its
subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC
and its related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, LLC. All Rights Reserved.

Important Telephone Numbers
Clinician’s office
To send data

Special Instructions

SJM Confirm™ Patient Activator User’s Manual i
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
What is the SJM Confirm PA? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
How does my monitoring system work? . . . . . . . . . . . . . . . . . . . . . . . . 1
What is the implant procedure like? . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
What is recovery like? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
What is a follow-up visit like? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
What do I do after I record my heart’s
electrical activity with the PA? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Why do I need an identification card? . . . . . . . . . . . . . . . . . . . . . . . . . . 3
When can I begin using the PA? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
What special precautions do I need
to follow? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Important Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Using The PA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

ii Table of Contents
Caring for the PA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Technical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
RF Operating Frequencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Storage and Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

SJM Confirm™ Patient Activator User’s Manual 1
Introduction
Your clinician has determined that it is beneficial for you to have a monitoring system to help identify
the cause of symptoms you experience. Your monitoring system consists of the St. Jude Medical™
SJM Confirm™ implantable cardiac monitor and the St. Jude Medical SJM Confirm external patient acti-
vator. This booklet answers some common questions about your monitoring system and explains how to
use the SJM Confirm external patient activator (PA).
What is the SJM Confirm PA?
The PA is an external handheld device, similar to a handheld computer. The PA uses radio waves to com-
municate with your implanted device. The PA initiates recording of the heart’s electrical activity by your
implanted device, reads stored data from your implanted device, and sends stored data to a clinician.
How does my monitoring system work?
Your monitoring systems works in two ways:
•Automatically. Your clinician will set your device to monitor and record your heart’s electrical activity.
•On Command. When you experience symptoms, you can use the PA to tell your device to record
your heart’s electrical activity. Your clinician will identify the symptoms for which you will record your
heart’s electrical activity. You can record this information at the beginning of this book.

2Introduction
What is the implant procedure like?
The implant typically involves a simple surgical procedure. The doctor numbs the area with local anaes-
thesia, makes a small incision, and places the device just under the skin in the upper chest through the
small incision.
What is recovery like?
Your clinician may ask you to limit some of your activities because of your symptoms. In general, people
who have a device can perform almost all their normal activities. Your clinician will also give you informa-
tion about caring for your incision and bathing.
What is a follow-up visit like?
You will go to your clinician’s office or clinic for follow-up visits. During a follow-up visit, your clinician
uses a programmer, a specialized computer, to review information stored in your device. Your clinician
can also use the programmer, without surgery, to change how your device is set up. Your clinician uses
the information from your device to help identify the cause of symptoms you experience.
An office visit usually lasts about 30 minutes or less. Your clinician will determine your follow-up visit
schedule.
What do I do after I record my heart’s electrical activity with the PA?
Your clinician will give you specific instructions on what to do after you record your heart’s electrical activ-
ity with the PA.

SJM Confirm™ Patient Activator User’s Manual 3
Why do I need an identification card?
You will be given an identification card with information about your device and the PA. Put the card in
your wallet or carry it with you at all times. Show your card if you are ever in an emergency, are admitted
to a hospital, see a new doctor, or need to prove that you have a device.
When can I begin using the PA?
In most cases, you can begin using the PA immediately after your device is implanted. Your clinician will
give you instructions on when to use the PA.
What special precautions do I need to follow?
Your device and the PA are not magnetic and have no moving parts. However, you should avoid devices
which generate a strong electric or magnetic interference (EMI). EMI could cause inappropriate data stor-
age or prevent data storage. Moving away from the source of EMI or turning it off will usually allow the
device or the PA to return to its normal mode of operation.
You should always use caution with the following:
•Medical procedures. Although your device should be unaffected by most medical procedures, you
should notify your doctor, dentist, physical therapist, chiropractor, or any other health care provider
that you have a device.
•Communication equipment. Communication equipment such as microwave transmitters or high-
power amateur transmitters may generate enough EMI to interfere with the performance of your
device or the PA if you are too close to the source of EMI.

4Introduction
•Wireless communication devices. Wireless communication devices such as computers that operate
on a wireless network, handheld personal computers (PDA), cellular phones, and even cordless tele-
phones may generate enough EMI to interfere with the performance of your device or the PA if you
are too close to the source of EMI.
•Household appliances. Household appliances such as microwave ovens, electric blankets, and
power tools should not damage your device or the PA. However, they may interfere with the perfor-
mance of your device or the PA.
•Industrial equipment. A variety of industrial equipment may generate enough EMI to interfere with
the performance of your device or the PA. These include, but are not limited to: arc welders; induction
furnaces; very large or defective electric motors; and internal combustion engines with poorly
shielded ignition systems.
•Metal detectors and security systems. Metal detectors found in airports and government build-
ings, and electronic article surveillance/anti-theft (EAS) systems such as those at the point of sale and
entrances/exits of stores, libraries, banks, etc., emit signals that may interfere with the performance of
your device or the PA. To minimize the possibility of interference, simply walk through these areas at a
normal pace and avoid lingering near or leaning on these systems. If your device triggers an alarm,
show your identification card to security personnel.
•Cellular phones. The device has been tested for use with cellular phones. Based on the results of the
tests, the device should not be affected by the normal operation of cellular phones when used more
than 15 cm from the device.
To minimize the possibility of interference, do not carry a cellular phone in a breast pocket or on a belt
within 15 cm of the device. Use a cellular phone on the side of your body opposite from the device.

SJM Confirm™ Patient Activator User’s Manual 5
Important Safeguards
Basic safety precautions should always be followed when using electrical products, especially when chil-
dren are present. These include the following:
• READ ALL INSTRUCTIONS BEFORE USING.
• DANGER! To reduce the risk of shock:
- Do not use the PA while bathing.
- Do not place or store the PA where it can fall or be pulled into a tub or sink.
- Do not place or drop the PA into water or other liquid.
• WARNING! To reduce the risk of burns, shock, fire, or injury to persons:
- Supervision is necessary when the PA is used by, on, or near children.
- Use the PA only for its intended use as described in this manual.
- Never operate the PA if it is not working properly, if it has been dropped or damaged, or if it has
been dropped into water or other liquid. Contact Technical Support (page 11) for service or
replacement instructions.
- Never drop or insert any object into any opening of the PA.
- Do not use the PA near flammable substances.
• To reduce the risk of damage to the PA:
- Do not transport or store the PA in a location where the temperature could reach higher than
55ºC or lower than -20ºC.
• KEEP THESE INSTRUCTIONS.

6Using The PA
Using The PA
You will use the PA to do a variety of things. Your clinician will tell you when to do the following:
•Record Data. Begin data recording in your implanted device.
•Read Data. Read the data stored in your device and transfer the data to the PA.
•Send Data. Send the data stored in the PA using your telephone line.
•Clear Data. Remove all stored data from the PA.
Note
You can record important telephone numbers and special instructions at the
beginning of this book.

SJM Confirm™ Patient Activator User’s Manual 7
Figure 1. Patient Activator - front and top
1
4
5
32
4
5

8Using The PA
1 Record button
2 Read button
3 Send button
4 Red lights
5 Yellow lights
6 PA speaker

SJM Confirm™ Patient Activator User’s Manual 9
Figure 2. Patient Activator - back

10 Battery Status
Battery Status
The PA is designed to record data on command once a week, read data from your implanted device once
a month, and send data once a month. Under these conditions you can expect the PA battery to last
about 3 years. Sending data more than once a month will drain the battery sooner.
Caring for the PA
The PA is designed to be used as indicated; however, it is an electronic device and susceptible to many
environmental stresses. Take care to avoid damaging the PA.
If necessary, you can clean the outside of the PA with a cloth dampened with water. The PA is classified as
IPX0 because it is not waterproof. Do not immerse the PA in any liquid.
There is no shut down procedure for the PA. The battery is not intended to be removed while in use.
The PA does not contain any user-serviceable parts. Do not open the case. Preventive maintenance,
including periodic safety checks, is not required for this device. Do not modify the PA. If there is a problem
with the PA, contact Technical Support (page 11).
Glossary
•Clinician — The person that you see at your doctor’s office. This may be your doctor, a nurse, a tech-
nician, or someone else that works for your doctor. This may also be the person you call to send data.

SJM Confirm™ Patient Activator User’s Manual 11
•Device — The implanted part of your monitoring system; records your heart’s electrical activity.
•Patient activator (PA) — The external handheld equipment that you use to record, read, and send
data from your device.
Technical Support
If you have any trouble using the PA or have any questions regarding its use or maintenance, contact
Technical Support.
St. Jude Medical maintains 24-hour phone lines for technical questions and product support:
• 1 818 362 6822
• 1 800 722 3774 (toll-free within North America)
• + 46 8 474 4147 (Sweden).

12 Symbols
Symbols
The following symbols may be found on the product or product label:
Record Data button
Read Data button
Send Data button
Telephone handset symbol
Done action
Retry action

SJM Confirm™ Patient Activator User’s Manual 13
Do not use in MRI scan room
Method of sterilization using ethylene oxide
Caution, consult accompanying documents.
European conformity, affixed according to the relevant provisions of AIMD
directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St. Jude
Medical declares that this device complies with the essential requirements
and other relevant provisions of these directives.
The full text of the European Union RE directive 2014/53/EU declaration of
conformity is available at the following internet address:
www.sjmglobal.com/euconformity.
This product operates between 9 and 200 kHz with an H-field strength of
less than 25 dBμA/m at 10 m.
Date of manufacture
STERILE EO

14 Symbols
Manufactured by
Use by
Do Not Reuse
Batch code
Serial number
Reorder number