St. Jude Medical SJM Confirm DM2100A Bedienungsanleitung

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

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.

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