Medtronic 2020A2 Technical Manual

CARDIOSIGHT®
READER

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Model 2020A

Technical manual

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

The following list includes trademarks or
registered trademarks of Medtronic in the
United States and possibly in other countries.
All other trademarks are the property of their
respective owners.

Medtronic and CardioSight

Explanation of symbols on the device

For US audiences only

Medical equipment with
respect to electric shock, fire,
and mechanical hazards,
only in accordance with
AAMI/ES 60601-1 (2006)/A2
(2010) and CSA 22.2 NO
60601-1 CAN/CSA:2008

Type BF applied part
(internally powered)

Direct Current

Resin recycling. Other
plastics, including acrylic,
acrylonitrile butadiene
styrene, fiberglass, nylon,
polycarbonate, and polylactic
acid.

Non-ionizing electromagnetic
radiation

Caution

Consult instructions for use

Product documentation

Accessories

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

Serial Number

Model or re-order number

Manufacturer/Date of
manufacture

Storage temperature
limitation

Humidity limitation

Battery

Package contents

Monitor

Power button

Telephone connection

Contents

Introduction 7

Indications for use 8

Contraindications 8

Warnings 8

Precautions 10

About the Reader 11

Choosing a place to set up the Reader 11

Setting up the Reader 12

Using the Reader 17

Green status lights and troubleshooting 20

Orange status lights and troubleshooting 21

Caring for the Reader 24

Reader specifications 24

5

Introduction

Display

Antenna

Power

The CardioSight Reader
Model 2020A (“Reader”), allows
clinics to interrogate certain
Medtronic implantable devices.
The implantable device data is
sent to a server over an analog
phone line. A report with the
implantable device data is sent to
the clinic.

Note: Refer to the Clinician
Information Sheet for a list of
Medtronic implanted devices that
are compatible with the Reader.

Figure 1 Reader (front view)

7

Indications for use

The Medtronic CardioSight
Reader Model 2020A is a portable
interrogation and data transfer tool
used with Medtronic implantable
cardiac devices.

Contraindications

There are no known
contraindications for the Reader.

Warnings

■

For use with Medtronic
implantable cardiac devices
only.

■

Do not modify this equipment.
Modifications may reduce
system effectiveness and
impact patient health.

■

Save this manual.

■

Do not touch the open
telephone plugs or insert your
finger or any objects into the
open telephone plugs on the
Reader. Inserting your finger
or objects into the open
telephone plug may result in
electrical shock.

8

■

Do not use the antenna if the
Reader does not operate as
described in “Using the
Reader” on page 17. Check
the batteries as described in
“Battery status” on page 21. If
you need further assistance,
contact your Medtronic
representative.

■

Important safety instructions
follow. When using the
Reader, basic safety
precautions should always be
followed to reduce the risk of
fire, electric shock, and injury
to persons, including the
following precautions:

– Do not use the Reader near

water, for example, near a
bath tub, wash bowl,
kitchen sink or laundry tub,
in a wet basement, or near
a swimming pool.

– Avoid using the Reader

during an electrical storm.
There may be a remote risk
of electric shock from
lightning.

– Do not use the telephone to

report a gas leak in the
vicinity of the leak. Do not
use the Reader to send
information if you suspect a
gas leak.

9

– Use the Reader only with a

UL Listed 26 gauge (AWG)
telephone line cord.

Precautions

■

Do not use a cellular phone
while the antenna is
positioned over the implanted
device. A mobile/cellular
phone could interfere with the
wireless communication
between the implanted device
and the Reader, and optional
cellular accessory (page 16).

■

If you are using a telephone
line that requires you to dial a
number (usually 9) to make an
outside call, make sure that
the telephone line settings are
correct. See “Verifying the
telephone line settings” on
page 14.

■

The Reader is designed for
use in the continental United
States, Alaska and Hawaii.

■

Do not bring the Medtronic
CardioSight Reader
Model 2020A into Zone 4
(magnet room), as defined by
the American College of
Radiology. It is MR Unsafe.

10

About the Reader

CARDIOSIGHT

T

M

READER

The Reader uses an antenna
(Figure 2) that is permanently
attached to the Reader to gather
information from the implanted
device.

-

Figure 2 Antenna (back view)

Choosing a place to set up the Reader

Consider the following
recommendations for choosing a
place to set up the Reader:

■

Put the Reader in a place
where the patient can sit
comfortably and the front of
the Reader is visible.

11

■

The Reader must be
connected to an analog
telephone socket. Use either
the telephone cord provided
with the Reader or any
telephone cord with standard
connectors.

■

Before using the Reader, turn
off any television sets or
computer monitors that are
within 6 feet of the Reader, its
antenna, or optional cellular
accessory (page 16.)

■

Do not place the Reader
anywhere it could get wet.

Caution: Do not get the
Reader wet. Water can
damage the Reader. If the
Reader is exposed to water,
contact your Medtronic
representative.

Setting up the Reader

Before you use the Reader you
need to perform the following
tasks:

1. Call Medtronic at 1-800-577­3510 to activate the clinic’s
account before using the
Reader for the first time. You
will need to provide the serial
number located on the bottom
of the Reader.

2. Install four LR6 (AA) size
batteries.

12

3. Verify the telephone line
settings.

4. Connect the Reader to an
analog telephone socket.

You may connect a telephone to
the Reader, but the telephone is
not required for the Reader to
work properly. You may choose to
connect the Reader to a telephone
if you intend to leave the Reader
set up continually.

Installing batteries

The Reader requires four LR6
(AA) size batteries. The battery
compartment is located on the
bottom of the Reader.

1. Open the battery
compartment by pushing the
latch upward.

2. Figure 3 shows how to install
batteries.

3. Close the battery
compartment. The battery
compartment is fully closed
when the latch clicks.

Note: Use only recommended
batteries. Using different
batteries may damage the
monitor.

13

Figure 3 Installing batteries

Verifying the telephone line
settings

Before using the Reader, verify
that the telephone line settings are
correct. There are two telephone
line settings on the Reader. See
Figure 4.

Figure 4 Telephone line settings

TONE-PULSE selects a tone or
pulse telephone line. There are
two positions for the switch.

14

NONE-7-8-9 determines if a

Optional

Telephone socket

number needs to be dialed to
reach an outside telephone line.
There are four positions for the
switch. Typically, the number 9 is
used when a number needs to be
dialed to reach an outside line.

Telephone line settings may be
selected when the Reader is on or
off.

Select the settings that are
appropriate for the telephone line
you will be using.

If you have questions about the
phone line, contact your local
phone carrier.

Connecting the Reader to a
telephone socket

Figure 5 Reader connected to a

telephone socket (the telephone is

optional).

15

Note: An optional cellular

Line Phone

accessory is available for use
where no conventional home
telephone (land line) exists. To
learn more about this option,
contact your Medtronic
representative. The instructions
for use that accompany the
cellular accessory are to be used
in conjunction with this manual to
ensure appropriate installation
and use. Refer to the cellular
accessory instructions for use if no
land line is available and a cellular
connection will be used.

To set up the Reader, you need to
perform the following tasks:

1. Make sure that you have the
Reader and the telephone
cord.

2. Locate the plugs on the left
side of the Reader.

Figure 6 Telephone plugs

3. Plug one end of the telephone
cord into the Line plug on the
left side of the Reader. See
Figure 6.

16

4. Plug the other end of the
telephone cord into an analog
telephone socket in the wall.

Note: For convenient use of
the Reader or the telephone,
plug the cord from a telephone
into the Phone plug on the
Reader.

Using the Reader

Note: If you must stop the session

before the session is complete,
remove the antenna from over the
implanted device and turn off the
Reader. When you are ready to
restart the session, follow steps 1
though 4.

1. Press the Power button on
the front of the Reader. The
green light above the Power
button blinks and then
remains lit.

2. Hold the antenna over the
implanted device so that the
Antenna Position Status light
is off. You may hold the
antenna snugly against the
patient’s clothing or skin. The
hand strap should be facing
out and away from the patient
when you are holding the
antenna over the implanted
device. See Figure 7.

17

Reposition the antenna if the

Power
button

Battery

status light

orange)

Reading

status

lights

(green)

Sending

status

lights

(green)

Sending

complete

light

(green)

Antenna
position

status light

(orange)

Telephone
line status

light (orange)

Power
status

light

(green)

orange Antenna Position
Status light starts blinking.
See Figure 8.

Figure 7 Positioning the antenna

3. Observe the status lights on
the display panel on the front
of the Reader to determine
the status of the information
being read and sent. See
Figure 8.

Figure 8 Power button and status

lights

18

Each of these status lights has a
different meaning when using the
Reader to send implanted device
information.

4. The five green Reading
Status lights fill as the Reader
gathers information from the
implanted device.

While the Reading Status
lights are blinking, have the
patient remain seated and
make sure the Reader
antenna is placed over the
implanted device. This
process typically takes less
than three minutes. When the
Reader finishes collecting
data from the implanted
device, these status lights
stop blinking and turn off. The
Reader beeps twice and
automatically dials the
preprogrammed 800 number.

5. When you hear the Reader
dialing, remove the antenna
from the implanted device.
Place the antenna back into
the storage space.

Note: The Reader may emit
high-pitched tones when
dialing the preprogrammed
number.

19

6. The three green Sending
Status lights start blinking
when the Reader is sending
data. This process typically
takes less than three minutes.

When the Reader is sending
data, the telephone line is not
available to make or receive
calls.

When the Reader finishes
sending information, the
Sending Complete light
illuminates and the Reader
emits two beeps.

The Reader shuts off
automatically after 2 minutes,
or you may press the Power
button to turn it off.

Green status lights and troubleshooting

The green lights indicate data
reading status and data sending
status. See Figure 8.

If the Reading Status lights stop
blinking and remain lit for more
than three minutes, press the
Power button and repeat steps
1 through 4.

If the Reader is turned off before
the data is read, repeat steps
1 through 4.

20

If the Sending Status lights remain
lit for more than one hour, turn off
the Reader and repeat steps
1 through 4.

If the Reader is turned off before
your data is sent, repeat steps
1 through 4.

Orange status lights and troubleshooting

The three orange lights on the
front of the Reader are status
lights. See Figure 8.

The status lights are:

■

Battery Status

■

Antenna Position Status

■

Telephone Line Status

The orange status lights should
not be lit when you are using the
Reader. If any of these status
lights remain on or you hear short
beeps after pressing the Power
button, try the recommendations
in the following paragraphs.

Battery status

If the orange battery status light
blinks and you hear continuous
beeps, the batteries are low and
should be replaced. If no status
lights come on after pressing the
Power button, verify that the
batteries are installed correctly.

21

Replace the batteries if necessary.
See “Installing batteries” on
page 13.

Antenna position

If the orange antenna position
status light begins blinking and
you hear short beeps, check the
following items:

■

Make sure the hand strap on
the top of the antenna is
facing out and away from the
patient. See Figure 7.

■

Reposition the antenna over
the implanted device.

When the antenna is repositioned
correctly, the orange antenna
position status light turns off, the
green status lights begin blinking
and the Reader resumes data
collection.

Telephone line status

If the Reader beeps and the
telephone line status blinks, check
the following items:

■

Check that the telephone line
settings are correctly
positioned. See Figure 4. If
you need help determining the
type of telephone line, contact
your local phone carrier.

22

■

Test the telephone line to
make sure it is working by
making an outside call using
the telephone connected to
the Reader. If the telephone
connected to the Reader is
not working, try another
telephone that is connected to
a different telephone socket.

■

Telephone line settings may
be selected when the Reader
is on or off.

■

Ensure that the Reader is
connected to an analog phone
line and not a digital PBX
system.

Warning: Do not touch the open
telephone plugs or insert your
finger or any objects into the open
telephone plugs on the Reader.
Inserting your finger or objects into
the open telephone plugs may
result in electrical shock.

Note: If the call was interrupted
due to Call Waiting, the Reader
automatically redials and sends
the implanted device information.
If the Reader does not begin
redialing, check that the telephone
connections are intact.

23

Caring for the Reader

Avoid dropping the Reader on a
hard surface. Contact your
Medtronic representative if the
Reader has been dropped and
does not function.

The Reader does not require any
preventative inspection or
maintenance.

You can clean the outside with a
clean, dry cloth.

While cleaning, be sure to not let
any water get into the enclosure.
Let the enclosure completely dry
before operating.

Caution: Do not get the Reader
wet, because water can damage
it. If the Reader is exposed to
water, contact your Medtronic
representative.

Reader specifications

Standards (The Reader
complies with the following
standards:)

EMC: CFR 47 Part 15

Patient Safety: ETL; cETL; IEC
60601-1, Type BF applied part
(Antenna), continuous operation,
internally powered, not suitable for
use in the presence of a
flammable anaesthetic mixture
with air or with oxygen or nitrous
oxide.

24

Power requirement

Voltage: 6 VDC nominal

Power: 300 mA nominal

Battery type: 4 LR6 (AA) size
alkaline

Recommended environmental
conditions during storage and
transport

■

Temperature: -40 °C (-40 °F)
to 65 °C (150 °F)

■

Relative humidity: Up to 95%

■

Note: Product remains safe
when stored or transported in
temperatures from -40 °C
(-40 °F) without relative
humidity control, to less than
or equal to 70 °C (158 °F) at a
relative humidity of less than
or equal to 93%,
non-condensing.

■

When the equipment is to be
stored for an extended period
of time, remove the batteries.

25

Recommended operating
conditions

■

Temperature: 9 °C (49 °F) to
43 °C (110 °F)

Note: Product remains safe
when operated at
temperatures from 5 °C
(41 °F), to less than or equal
to 43 °C (110 °F), in relative
humidity from 15% to 93%,
non-condensing, and in
atmospheric pressures from
700 hPa to 1060 hPa.

Disposal

Follow local regulations for proper
disposal of this product. Do not
dispose of this product in the
unsorted municipal waste stream.
This product contains materials
that can harm the environment.

Testing

Electromagnetic Compliance
(EMC) testing shows that the
Reader provides reasonable
protection against harmful
interference in a typical medical
installation. However, there is no
guarantee that interference will
not occur in a particular
installation. If the Reader does
cause harmful interference to

26

other devices or is negatively
impacted by other devices, the
user is encouraged to try to
correct the interference by one or
more of the following measures:

■

Reorient or relocate the
devices.

■

Increase the separation
between the devices.

■

Consult Medtronic for help.

Refer to the EMC Declaration
manual included with the monitor
for additional EMC information.

The Reader has been tested for
compliance to FCC regulations.
Changes or modifications of any
kind not expressly approved by
Medtronic could void the user’s
authority to operate the Reader.

Consumer Information and FCC
Requirements

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.

27

1. This equipment complies with
Part 68 of the FCC rules. On the
bottom of this equipment is a
label that contains, among other
information, the FCC
registration number and Ringer
Equivalence Number (REN) for
this equipment. If requested,
provide information to your
telephone company.

2. The REN is useful to determine
the quantity of devices you may
connect to your telephone and
still have all of those devices
ring when your number is
called. In most, but not all
areas, the sum of the REN's of
all devices should not exceed
five (5.0). To be certain of the
number of devices you may
connect to your line, as
determined by the REN, you
should call your local telephone
company to determine the
maximum REN for your calling
area.

3. If your Model 2020A Medtronic
CardioSight Reader causes
harm to the telephone network,
the Telephone Company may
discontinue your service
temporarily. If possible, they will
notify you in advance. But if
advance notice isn't practical,
you will be notified as soon as
possible. You will be advised of
your right to file a complaint with
the FCC.

28

4. Your telephone company may
make changes in its facilities,
equipment, operations, or
procedures that could affect the
proper operation of your
equipment. If they do, you will
be given advance notice so as
to give you an opportunity to
maintain uninterrupted service.

5. If you experience trouble with
this equipment, Model 2020A
Medtronic CardioSight Reader,
please contact Medtronic, Inc.
Minneapolis, MN,
1-800-929-4043, for repair/
warranty information. The
telephone company may ask
you to disconnect this
equipment from the network
until the problem has been
corrected or you are sure that
the equipment is not
malfunctioning.

6. There are no repairs that can be
made by the customer to the
Model 2020A Medtronic
CardioSight Reader.

7. This equipment may not be
used on coin service provided
by the telephone company.
Connection to party lines is
subject to state tariffs. Contact
your state public utility
commission or corporation
commission for information.

29

Medtronic, Inc.

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical
consultation for physicians and
medical professionals)
Bradycardia: [phone]
Tachycardia: [phone]

Europe/Middle East/Africa

Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
[phone]

Technical manuals

www.medtronic.com/manuals

© Medtronic, Inc. 2013 M954354A001B

2013-10-28

*M954354A001*