Medtronic 9538 Users Manual

®

REVEAL

Patient Assistant 9538/9539

Clinician Manual

Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.

The following are trademarks of Medtronic:

EC REP

Medtronic and Reveal

Explanation of symbols:

Conformité Européenne (European Conformity). This symbol means that the device fully complies with
AIMD DIrective 90/385/EEC (NB 0123) and R&TTE 1999/5/EC.

Package contents

Patient Assistant model 9538

Patient Assistant model 9539

Product documentation

For U.S. audiences only

Temperature limitation

Authorized representative in the European Community

Manufacturer

Consult instructions for use

Date of manufacture

Serial number

Reorder number

Medical equipment with respect to electric shock, fire, and mechanical hazards, only in
accordance with UL2601-1, and CAN/CSA C22.2 no. 601.1

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this
product according to local regulations. See http://recycling.medtronic.com for instructions on
proper disposal of this product.

Battery polarity as shown

Type BF equipment

Battery condition

Position of Cell

RF transmitter

Humidity Limitation

Contents

Explanation of symbols: 2

1 Description and intended use 7

1.1 Reveal Patient Assistant model 9538 8

1.2 Reveal XT Patient Assistant model 9539 8

2 Package contents and inspection 9

2.1 Contents of the Patient Assistant package 9

2.2 Inspection 9

3 Preparing the Patient Assistant for patient use 10

4 Recording cardiac rhythm data 10

4.1 How to record cardiac rhythm data 10

4.2 Response when a recording is requested 12

5 Checking for cardiac rhythm events 13

5.1 How to check for cardiac rhythm data storage 13

5.2 Response when a query is requested 14

6 Troubleshooting 15

7 Battery information 16

7.1 Replacement batteries 16

7.2 When to install batteries 16

7.3 How to install new batteries 16

8 Attaching the optional wrist strap 18

9 Maintenance 18

9.1 Care and handling 18

9.2 Cleaning 19

9.3 Service 19

9.4 Disposal 19

10 Specifications 20

10.1 Device specifications 20

10.2 Safety and compatibility standards 20

1 Description and intended use

The Reveal Patient Assistant model 9538 and the Reveal XT
Patient Assistant model 9539 are handheld, battery-operated,
radio-frequency devices used to communicate with the Reveal
Insertable Cardiac Monitor. See the Reveal Clinician Manual
provided with the Insertable Cardiac Monitor for specific
compatibility information.

The Patient Assistant is intended for unsupervised patient use
away from a hospital or clinic. The Patient Assistant activates one
or more of the data management features in the Reveal Insertable
Cardiac Monitor:

■

To verify whether the implanted device has detected a
suspected arrhythmia or device related event.

■

To initiate recording of cardiac event data in the implanted
device memory.

The Patient Assistant is not intended to detect or indicate the
presence or absence of medical conditions. Instruct the patient to
seek immediate medical attention if he or she is feeling ill,
regardless of indications from the Patient Assistant.

Reveal Patient Assistant

7

As directed by the clinician, the patient uses the Patient Assistant
during or immediately after a symptomatic event. By pressing a
button on the Patient Assistant and holding it in front of his or her
implanted device, patients may record the event into the memory
of the implanted device. At follow-up visits the implanted device
recording is used to check the patient’s cardiac rhythm and help
determine if the patient’s symptoms are cardiac related.

The patient should be advised to carry or keep their Patient
Assistant nearby at all times to avoid the possibility of missing an
opportunity to mark a symptomatic episode.

Caution: Do not take the Patient Assistant (handheld activator)
into the MRI controlled room (magnet room). Doing so can
damage the Patient Assistant or the MR scanner.

The physician should instruct the patient when to use the Record
Symptoms button (both models) and Query button (model 9539)
and what to do when a response indicator is received. The Reveal
Patient Manual provides a place to record such instructions. See
“Preparing the Patient Assistant for patient use” on page 10.

9538/9539 Clinician manual