Medtronic 2020A2 Technical Manual

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CARDIOSIGHT® READER
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Technical manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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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
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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
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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
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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)
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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.
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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.
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– 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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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Medtronic, Inc.
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636
Europe/Middle East/Africa
Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland +41 21 802 7000
Technical manuals
www.medtronic.com/manuals
© Medtronic, Inc. 2013 M954354A001B
2013-10-28
*M954354A001*
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