Medtronic 2020A2 Technical Manual

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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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.
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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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