Medtronic 2696 Users Manual

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MODEL 2696 INCHECK

Patient Assistant

Physician’s manual

TM

/

Caution: Investigational device.
Limited by federal law (USA) to
investigational use.

220875001 Rev A Printing instructions: doc#163256;

refer to “Implant man.” row in the
applicable table.

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Explanation of symbols on the packaging and literature

w

Attention: See accompanying documentation

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y

n

i
c

only

Type BF equipment

Battery polarity as shown

Serial number

Storage temperature

For United States audiences only

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

Medical device

Telemetry (communication signal) status light lit

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Explanation of symbols on the device

AF?

Query button (Press to request implanted device
to check for AF)

OK symbol (AF is not present)

AF symbol (AF is present)

Therapy button (Press to instruct implanted
device to deliver atrial cardioversion therapy)

Record Symptoms button (Press to instruct the
implanted device to record cardiac activity)

Record symbol (recorded cardiac activity)

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y

Type BF equipment

Low Batteries symbol

Battery polarity as shown

w

c

only

220875001 Rev A Printing instructions: doc#163256;

Attention: See accompanying documents

For United States audiences only

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

refer to “Implant man.” row in the
applicable table.

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refer to “Implant man.” row in the
applicable table.

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Table of contents

1 Description and intended use 7

2 Contents of the Patient Assistant box 8

2.1 Inspection 9

2.2 Installation and setup 9

3 Checking the patient’s heart rhythm 9

3.1 How to check the patient’s heart rhythm 9

3.2 Response when a query is requested 12

4 Requesting atrial cardioversion therapy 13

4.1 How to request cardioversion therapy 13

4.2 Response when therapy is requested 15

4.3 When the Therapy button will appear 16

4.4 If therapy is not delivered 16

5 Recording cardiac information 17

5.1 How to record cardiac information 17

5.2 Response when record symptoms is requested 18

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6 Battery information 19

6.1 Replacement batteries 19

6.2 When to install batteries 19

6.3 How to install new batteries 20

7 Maintenance 21

7.1 Care and handling 21

7.2 Cleaning 22

7.3 Service 22

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7.4 Disposal 22

8 Troubleshooting 23

9 Specifications 25

9.1 Device specifications 25

9.2 Safety and compatibility standards 26

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1 Description and intended use

The Model 2696 InCheckTM Patient Assistant shown on Figure 1
is a hand-held, battery powered, radio frequency communication
device. The Patient Assistant communicates with certain
implantable Medtronic cardiac devices that provide patient­activated features. See the manual for the implanted device for
compatibility information.

The Patient Assistant can send simple programming commands
to the implanted device, and receive and display information about
the patient’s cardiac rhythm.

Telemetry status

light

AF?

Query button, press to check

for AT/AF episode detection

Record Symptoms
button, press to
record cardiac event
data

Symbol and button

display area

Wrist strap
connector

Figure 1. Patient Assistant (Not actual size)

Intended use – The Patient Assistant is intended for
unsupervised patient use away from a hospital or clinic. The
Patient Assistant activates one or more of the patient
management features in the implanted device, depending on the
implanted device model and the programmed features:

■

To verify whether the implanted device has detected a
suspected atrial arrhythmia.

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■

To initiate recording of cardiac event data in the implanted

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device memory.

■

To request atrial cardioversion therapy, if supported by the
implanted device and patient activated therapy has been
previously programmed by the physician. Therapy is allowed
when the implanted device is currently detecting an atrial
arrhythmia episode and all conditions for delivering therapy
have been met.

Note:

■

Ventricular arrhythmia therapy cannot be patient activated
using the Patient Assistant.

2 Contents of the Patient Assistant box

The following should be found in the Patient Assistant box:

■

One Patient Assistant

■

Two N-size 1.5 V batteries

■

One carrying case

■

One wrist strap

■

One physician’s manual

■

One quick reference guide/patient ID card

■

Two warranty cards (USA and outside USA)

■

One patient manual

The Patient manual includes blank lines in sections 3 and 7 for the
patient’s prescription information. This information includes when
to use the Patient Assistant, which button to press and what
actions to take for each reply.

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The Quick Reference Guide/Patient ID Card provides a more
portable version of the basic instructions for using the Patient
Assistant. Blank lines are provided for name and telephone
number information.

2.1 Inspection

Inspect the Patient Assistant for damage or defects. If the case is
cracked or other defects are discovered, return the Patient
Assistant to Medtronic.

2.2 Installation and setup

Place new batteries in the Patient Assistant (see page 20).
Press either front panel button to test the Patient Assistant. The

telemetry status light flashes green for about 15 seconds, and the
Patient Assistant gives a short beep. This confirms that the
batteries can operate correctly.

Provide the necessary information in the Patient manual and
Quick Reference Guide/Patient ID Card.

Refer to the implantable device reference manual for information
about its features that apply to the Patient Assistant.

3 Checking the patient’s heart rhythm

3.1 How to check the patient’s heart rhythm

Note: The Patient Assistant may not communicate at full

strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).

1. Press the Query button. Verify that the telemetry status light
flashes green, and the Patient Assistant gives a short beep. If
these responses do not occur, see page 23.

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2. Place the Patient Assistant against the implanted device. See
Figure 2.

AF?

Figure 2. Positioning the Patient Assistant

3. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 3).

Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 3.

Note: Pressing the Therapy button will cause the implanted
device to deliver atrial cardioversion therapy. See page 16 for
information about when the Therapy button will appear.

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AF?

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Figure 3. Patient Assistant with all symbols displayed for reference

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3.2 Response when a query is requested

The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.

Display Definition

OK symbol: The implanted device is
not detecting an atrial

tachyarrhythmia episode.

AF symbol: The implanted device is
detecting an atrial tachyarrhythmia
episode.

Therapy button: Atrial cardioversion
therapy is allowed. See “Requesting
atrial cardioversion therapy” on
page 13 for more information.

Telemetry status light flashes
for about 15 seconds and
goes out.

The Patient Assistant did not
communicate with the implanted
device.

Low Batteries symbol: The Patient
Assistant batteries are low and should
be replaced soon.

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4 Requesting atrial cardioversion therapy

4.1 How to request cardioversion therapy

Note: The Patient Assistant may not communicate at full

strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).
Note: Pressing the Therapy button will cause the implanted

device to deliver atrial cardioversion therapy. See page 16 for
information about when the Therapy button will appear.

1. Instruct the patient to sit down or lie down in a comfortable
position. Use the wrist strap if desired.

2. Press the Query button. Verify that the telemetry status light
flashes green, and the Patient Assistant gives a short beep. If
these responses do not occur, see page 23.

3. Place the Patient Assistant against the implanted device (see
Figure 4).

A
F?

Figure 4. Positioning the Patient Assistant

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4. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 5).

Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 4.

5. Press the Therapy button (if lit after pressing the Query
button). The telemetry status light will flash red.

Note: The Therapy button will stay lit for about 10 seconds
after the query. If the Therapy button goes out before it can be
pressed, repeat steps 1 through 4.

6. Place the Patient Assistant against the implanted device.

7. Listen for a long beep and look to see if the telemetry status
light is solid red. Lift the Patient Assistant to see what appears
on the display area (Figure 5).

Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 7.

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AF?

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Figure 5. Patient Assistant with all symbols displayed for reference

4.2 Response when therapy is requested

The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.

Display Definition

OK symbol: The implanted device is not
detecting an atrial tachyarrhythmia

episode. Appears if the AF has stopped
since pressing the Query button.

AF symbol: The implanted device is
detecting an atrial tachyarrhythmia
episode.

(flashing)

Flashing Therapy button: Therapy will
be delivered soon. In most cases,
therapy will be delivered in about
10 seconds. The maximum time it takes
the implanted device to prepare to deliver
therapy is about 1 minute.

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Display Definition

No Therapy button. Therapy will not be delivered.

Telemetry status light is solid red with no
flashing button. See section 4.4.

Telemetry status light
flashes for about

The Patient Assistant did not
communicate with the implanted device.

15 seconds and goes out.

Low Batteries symbol: The Patient
Assistant batteries are low and should be
replaced soon.

4.3 When the Therapy button will appear

The Therapy button appears after pressing the Query button
when the following conditions are met:

■

The implanted device supports patient activated therapy.

■

Patient activated therapy is enabled in the implanted device.

■

The patient is in AT/AF.

■

All conditions to deliver atrial therapy are met.

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4.4 If therapy is not delivered

If the Patient Assistant gives a long beep and the Therapy button
goes dark without flashing, the atrial cardioversion therapy was
cancelled before delivery. The typical reasons are:

■

The atrial rate cannot be confirmed.

■

The ventricular rate is too fast.

Refer to the reference manual for the implanted device for more
possible explanations and programming options.

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5 Recording cardiac information

5.1 How to record cardiac information

Note: The Patient Assistant may not communicate at full

strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).

1. Press the Record Symptoms button. Verify that the telemetry
status light flashes green, and the Patient Assistant gives a
short beep. If these responses do not occur, see
“Troubleshooting” on page 23.

2. Place the Patient Assistant against the implanted device. See
Figure 6.

AF

?

Figure 6. Positioning the Patient Assistant

3. Listen for a long beep or look to see if the telemetry status light
is solid green. Lift the Patient Assistant to see what appears
on the display area (Figure 7).

Note: If the Patient Assistant does not respond in about
15 seconds, it did not communicate successfully with the
implanted device. Repeat steps 1 through 3.

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AF?

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Figure 7. Patient Assistant with all symbols displayed for reference

5.2 Response when record symptoms

is requested

The Patient Assistant displays the appropriate symbols for about
10 seconds after receiving a response from the implanted device.

Display Definition

Record symbol: The implanted device
successfully recorded heart rhythm
information.

Telemetry status light
flashes for about 15 seconds
and goes out.

The Patient Assistant did not
communicate with the implanted
device.

Low Batteries symbol: The Patient
Assistant batteries are low and should
be replaced soon.

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6 Battery information

6.1 Replacement batteries

The Patient Assistant operates with two N-size 1.5 volt batteries.
The recommended battery type is alkaline manganese dioxide,
type ANSI/NEDA 910A and IEC LR1. This battery is available
from the following manufacturers:

■

Duracell Model MN9100

■

Kodak Model KN

■

Rayovac Model RN-2

■

Panasonic Model AM5

■

Varta Model 4001

■

Energizer Model E90

These batteries can be purchased at a retail store, camera store,
battery speciality store, electronics store, or from an Internet
retailer.

6.2 When to install batteries

■

Install new batteries before giving the Patient Assistant to a
patient.

■

If the Low Batteries symbol appears, replace both batteries
soon. The Patient Assistant will operate for several more uses
after the initial appearance of the Low Batteries symbol.

Note: Follow local regulations for proper disposal of used
batteries.

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6.3 How to install new batteries

1. Slide the battery cover tab toward the center of the Patient
Assistant and push upward to open the battery compartment.

Figure 8. Replacing the batteries.

2. Remove the old batteries.

3. Insert the new batteries according to the polarity shown on the
battery compartment.

4. Snap the battery cover closed.

5. Verify that the Patient Assistant beeps and that the telemetry
status light flashes when the Query button or the Record
Symptoms button is pressed. This confirms that the new
batteries have sufficient charge to operate the Patient
Assistant.

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7 Maintenance

7.1 Care and handling

The Patient Assistant is designed for robust use, to be carried and
handled on a daily basis. However, it is a precision electronic
instrument and precautions should be taken to avoid damage.

To preserve battery life, remove the batteries when the Patient
Assistant is not used for long periods of time or exposed to
temperatures below 15 °C (60 °F).

Electronic devices are susceptible to many environmental
stresses. Precautions should be taken to avoid damage to the
unit, including (but not limited to) those listed here.

Precautions:

■

To prevent unintentional delivery of patient-activated therapy,
instruct your patient not to carry the Patient Assistant in a
pocket directly over the implanted device.

■

Do not immerse the Patient Assistant in liquid.

■

Do not clean the Patient Assistant with solvents or chlorine
based cleansers (for example, nail polish remover or bleach).

■

Do not drop the Patient Assistant or mishandle it in a way that
might physically damage the Patient Assistant.

■

Avoid spilling fluid on the Patient Assistant. Do not immerse in
liquid.

■

Do not open the Patient Assistant, except to install batteries.

■

Do not sterilize the device by gamma irradiation and do not
steam sterilize (autoclave) the Patient Assistant.

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■

Electromagnetic interference (EMI) can impair the proper

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performance of the Patient Assistant. Normal operation can
be restored by moving away from the source of the
interference.

■

Other environmental factors may impact proper performance
of the Patient Assistant. Use of good electronic device
practices will help to prevent environmental damage to the
unit.

7.2 Cleaning

■

Be careful to prevent moisture from entering the Patient
Assistant. The Patient Assistant is moisture resistant, but not
waterproof.

■

Clean the outside of the Patient Assistant with a slightly damp
cloth. Mild household cleaners will not damage the case or
labels.

7.3 Service

The Medtronic Model 2696 InCheckTMPatient Assistant has been
carefully engineered, manufactured and quality tested to provide
long, trouble-free service. Should service or repair be necessary,
contact your local Medtronic representative at the appropriate
address or telephone number on the back cover of this document.
Please refer to the model number (Model 2696) and serial number
(located on the rear panel) when calling Medtronic.

7.4 Disposal

Follow local regulations for proper disposal of the Patient
Assistant at the end of its useful service life.

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8 Troubleshooting

The following list can be used to help solve possible problems with
the Model 2696 Patient Assistant.

Problem Possible causes Possible solutions

Telemetry status
light does not
flash, no beep.

The batteries are
inserted backwards.

The batteries are
depleted.

Re-install the batteries.

Replace the batteries.

Telemetry status
light flashes, no
beep.

Wrong type batteries.

A button is broken.

Component failure.

The speaker has
failed.

23

Verify that batteries are
N-size, 1.5 V.

Replace the Patient
Assistant.

Replace the Patient
Assistant.

• Use response on the
display area.

• Replace Patient
Assistant.

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Problem Possible causes Possible solutions

Telemetry status
light stops flashing
without a response
after the button
press.

Insufficient telemetry.
Patient Assistant did
not communicate

with the implanted
device.

Reposition Patient
Assistant.

• Improve Patient
Assistant position over
implanted device.

• Circle the Patient
Assistant slowly over
the implanted device.

Electromagnetic
interference.

• Move away from the
source of interference.

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Repeated failures Patient Assistant is

outside its

Move to warmer or cooler

surroundings.
temperature range:
8°C (16°F) to 43°C
(110 °F).

Patient Assistant
needs repair.

Contact a Medtronic

representative.

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9 Specifications

9.1 Device specifications

Dimensions: Approximately 96 mm x 56 mm x 22 mm

(3.77" x 2.20" x 0.86")
Power source: 2 N-size 1.5 volt batteries, alkaline (manganese

dioxide)

Battery dimensions: 10 mm diameter x 30 mm (0.39” x 1.18”)
Battery longevity: 180 uses minimum, when used once a day at

room temperature.
Operating temperature: 8 °C (16 °F) to 43 °C

(110 °F)
Transport and storage (batteries not installed):
Ambient temperature: -40 °C (-40 °F) to 66 °C (150 °F)

Relative humidity: up to 95%

Audible output level: 65 dBA minimum at 96 mm (6")
Classification with respect to electric shock: Internally

powered

Protection from electric shock (IEC 60601-1): Typ e BF
Protection against ingress of liquids: Ordinary equipment
Mode of operation: Short term

1

1

Operating the Patient Assistant below 15 °C (60 °F) for extended
periods of time will shorten battery longevity

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This device complies with Part 15 of the FCC Rules. Operation 
is subject to the following two conditions: (1) this device may not 
cause harmful interference, and (2) this device must accept any 
interference received, including interference that may cause 
undesired operation.

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9.2 Safety and compatibility standards

The Model 2696 Patient Assistant complies with the following
standards:

IEC 60601-1, Medical electrical equipment safety
IEC 60601-1-2, Electromagnetic compatibility
EN45502-1, Safety, marking and information of medical devices

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Sales offices:
Asia: Medtronic International Ltd.

Suite160216/F, ManulifePlaza,
The Lee Gardens, 33 Hysan Avenue,
Causeway Bay, Hong Kong
Tel. [phone] Fax [phone]

Medtronic Asia Ltd.
3 Floor Peter Building,
570-6 Shinsa-Dong Kangnam-ku,
Seoul 135-120, South Korea
Tel. [phone] Fax [phone]

Australia: Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road, Gladesville NSW 2111
Tel. [phone] Fax [phone]

Austr ia: Medtronic Österreich GmbH
Millennium Tower, Handelskai 94-96,
1200 Vienna
Tel. [phone] Fax [phone]

Belgium: Medtronic Belgium S.A.
Boechoutlaan 55, 1853 Strombeek-Bever
Tel. [phone] Fax [phone]

Canada: Medtronic of Canada Ltd.
6733 Kitimat Road, Mississauga,
Ontario L5N 1W3
Tel. [phone] Fax [phone]

Denmark: Medtronic-ViCare A/S
Birkerød Kongevej 150B, DK-3460 Birkerød
Tel. [phone] Fax [phone]

Finland: Medtronic Finland OY/LTD
Sahaajankatu 24, PO Box 230,
FIN-00810 Helsinki
Tel. [phone] Fax [phone]

France: Medtronic France S.A.S.
122, avenue du Général Leclerc,
92514 Boulogne-Billancourt Cedex
Tel. [phone] Fax [phone]

Germany: Medtronic GmbH
Emanuel-Leutze-Straße 20, 40547 Düsseldorf,
PO Box 110738
Tel. [phone] Fax [phone]

Osterfeldstraße 86, 85737 Ismaning,
Tel. [phone] Fax [phone]

Willhoop 1, 22453 Hamburg
Tel. [phone] Fax [phone]

Leipziger Chaussee 191g, 06112 Halle/Saale
Tel. [phone] Fax [phone]

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Greece: Medtronic Hellas S.A.

Agias Varvaras 5, 15231 Halandri, Athens
Tel. [phone] Fax [phone]

Italy: Medtronic Italia SpA
Viale Fulvio Testi, 280 - Scala A, 20126 Milano
Tel. [phone] Fax [phone]

Via Lucrezio Caro, 63, 00193 Roma
Tel. [phone] Fax [phone]

Japan: Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku,
Kawasaki, Kanagawa 210-0913
Tel. [phone] Fax [phone]

Latin America Headquarters: Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604 USA
Tel. [phone] Fax [phone]

The Netherlands: Medtronic B.V.
Earl Bakkenstraat 10, PO Box 2542,
6401 DA Heerlen
Tel. [phone] Fax [phone]

Norway: Medtronic Vingmed AS
Fjordveien 1, Postboks 366, 1323 Høvik
Tel. [phone] Fax [phone]

Portugal: Medical Implant Portugal, Lda.
Rua Tomás da Fonseca,
Torre E 8, andar A,B, 1600 - 209 Lisboa
Tel. [phone] Fax [phone]

Spain: Medtronic Ibérica, S.A.
Centro Empresarial Miniparc III, Edificio K,
Calle Caléndula, 93, El Soto de la Moraleja,
28109 Alcobendas – Madrid
Tel. [phone] Fax [phone]

Sweden: Medtronic AB
Dackevägen 33, Box 265, S-177 25 Järfälla
Tel. [phone] Fax [phone]

Switzerland: Medtronic (Schweiz) AG
Route du Molliau 31, Case Postale 84,
CH-1131 Tolochenaz
Tel. [phone] Fax [phone]

U.K. and Ireland: Medtronic U.K. Ltd.
Suite 1, Sherbourne House,
Croxley Business Center, Watford,
Herts WD1 8YE, United Kingdom
Tel. [phone] Fax [phone]

220875001 Rev A Printing instructions: doc#163256;

refer to “Implant man.” row in the
applicable table.

220875_bcv.fm 3/13/03 10:11 am
UC200203829 EN

4.625 x 6 inches (117 mm x 152 mm)

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. [phone]
Fax [phone]

Medtronic E.C. Authorized
Representative/Distributed by

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East
Headquarters

Medtronic Europe Sàrl
Route du Molliau 31
Case Postale
CH-1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. [phone]
Fax [phone]

Medtronic Confidential

implant_R02

© Medtronic, Inc. 2003
All Rights Reserved

*220875001*

220875001 Rev A Printing instructions: doc#163256;

220875001
March 2003

refer to “Implant man.” row in the
applicable table.