Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
MEDTRONIC CARELINK® 2090
Reference Manual
A guide for setting up and using the Medtronic CareLink 2090 Programmer.
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.
Index ................................................................... 106
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1 Introduction to the programmer
1.1 Explanation of packaging and product symbols
Refer to the package label and product to see which symbols apply to this product.
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with European Union Acts.
The use of this device might be subject to individual country licensing
regimes in Europe.
Caution
Consult instructions for use
System meets the applicable Canadian and U.S. IEC safety standards.
Type BF applied part
Type CF applied part
Serial number
Temperature limitation
For U.S. audiences only.
Off
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On
Wireless communication enabled
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.
RF transmitter
Caution: Strong magnet
The product fully complies with the Australian Communications and Media
Authority (ACMA) and the New Zealand Ministry of Economic Development Radio Spectrum Management standards for radio communications
products.
VGA monitor
Battery
Diskette
Network connection port
USB port
PCMCIA card slot
Microphone port
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Headphones port
Authorized representative in the European community
Alternating current
Date of manufacture
Manufacturer
Reorder number
Lot number
Humidity limitation
Package contents
Programmer, software installed
Product documentation
Accessories
Magnetic Resonance (MR) Unsafe
Software series number
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UL recognized component
China RoHS
Caution: Federal Law (USA) restricts this device to sale by or on the order
of a physician
The product complies with both Canadian and U.S. requirements for meeting UL safety standards
1.2 About this guide
This guide describes the features and functions of the Medtronic CareLink 2090
Programmer (referred to as the “programmer”).
Note: Screen images in this guide are for reference only. The content and presentation may
vary depending on user selections, desktop, and device being interrogated.
1.3 Description and intended use
The Medtronic CareLink 2090 Programmer is a portable, line-powered (AC)
microprocessor-based system with software to interrogate and program Medtronic and
Vitatron implantable devices. Other features include:
●
Automated software updates using a dial-up or local area network (LAN) connection,
depending on the hardware configuration. This connection allows the programmer to
program new devices and to provide new features as they become available.
●
A large, bright screen that is adjustable for viewing when sitting or standing.
●
Keyboard to make entering information easier.
●
Fast printing speed of 50 mm/s on recorder paper.
●
ECG recording and diagnostic data reporting. Refer to the technical manuals supplied
with the software and hardware accessories for specific details.
The Medtronic CareLink 2090 Programmer should be used by healthcare personnel only in
a clinical or hospital environment.
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1.4 Contraindications
There are no known contraindications to the use of the 2090 Programmer when not in a
device application. For contraindications specifically related to the implantable devices that
can be interrogated or programmed by the programmer, see the instructions for use for the
implanted device.
1.5 Warnings
These warnings apply in general to using the programmer for programming implantable
device parameter settings. For more information related to specific implantable device
models, see the reference guides for the implantable device and the programmer software.
Damage due to impact – Do not use the programmer if it has sustained impact damage.
Internal components may be damaged or exposed. Use of damaged equipment may impact
user or patient safety.
Defective equipment – If technical and safety inspection reveals a defect that could harm
the patient, clinicians, or third parties, the programmer should not be used until it has been
properly repaired. The operator must immediately notify Medtronic or Vitatron of these
defects.
Diagnostic ECG – Do not use the programmer ECG display for recording or diagnosis. Use
a separate ECG device if recording or diagnostic ECG capabilities are required.
Equipment compatibility – The programmer must be used only for interrogating and
programming compatible Medtronic or Vitatron implantable devices. If the programmer is
used on other implanted devices, direct stimulation through energy coupling may occur. The
programmer is not compatible with programmable devices of other manufacturers.
Flammable anesthetic mixture – The programmer is not suited for use in the presence of
a flammable anesthetic mixture.
Importance of reference documentation – Implantable device programming should be
done only after careful study of the reference guide for the implantable device and after
careful determination of appropriate parameter values based on the patient’s condition and
pacing system used. The implantable device reference guide contains a complete
description of implantable device operation and important information, such as indications
for use, contraindications, warnings, and precautions. The instructions contained in this
reference guide and the reference guide supplied with the programmer software are limited
to the mechanics of setting up the programmer and selecting the correct options for the
desired programming function. Improper use of the programmer could result in erroneous or
inadvertent programming and improper operation of telemetry and measurement functions.
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Internal electrodes – Do not connect the programmer to wires or electrodes internal to the
body. The programmer is designed to be medically safe only when attached to surface
electrodes.
Magnetic Resonance (MR) Unsafe – The programmer is MR Unsafe. Do not bring the
programmer into Zone 4 (magnet room), as defined by the American College of Radiology.
Measurement function – The programmer is also designed to detect and measure pulse
rate, AV interval and pulse width, and implantable device artifacts. The device takes these
digital measurements with the assistance of optional skin electrodes. Medtronic and Vitatron
make no claims or warranties as to the effectiveness of the programmer as a diagnostic tool
to the physician.
Modification of equipment – Do not modify this equipment. Modifications may reduce
system effectiveness and impact user or patient safety.
Telecom voltage limitation – When using a modem or combo card, make sure that the
telecom voltage does not exceed 125 V. Excessive voltage may damage the programmer.
1.6 Precautions
VGA monitor use – To protect against interference or surge/leak currents, the use of a
secondary VGA monitor must meet an applicable safety standard such as UL 60950-1 or
IEC 60950-1. The user is responsible for the safety of the resulting medical electrical system.
ECG cable integrity – Upon opening the package, if the ECG cable appears damaged, do
not use it. Contact your local Medtronic or Vitatron representative.
Care in handling ECG cable wire – Do not pull on the insulated cable wire to disconnect
the cable. Tension on the insulated cable wire may result in damage to the cable.
Electrocautery/external defibrillation – Do not position the programming head over an
implanted device during electrocautery or external defibrillation procedures.
Do not immerse – Take care to prevent liquid from entering the programmer and
programming head. Do not immerse the programmer or any accessories in any liquid or
clean them with aromatic or chlorinated hydrocarbons.
Autoclaving – Do not autoclave the programming head or ECG cable and lead wires.
Electromagnetic interference (EMI) – The programming head has been tested for
compliance with industrial and medical EMI regulations. Any use outside the patient
environment may result in the programming head malfunctioning.
Radio-frequency (RF) interference – Portable and mobile RF communications
equipment can interfere with the operation of the programmer. Although this system has
been approved, there is no guarantee that it will not receive interference or that any particular
transmission from this system will be free from interference.
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Damaged equipment – If the case of the programmer is cracked or if any of the connectors
are damaged, contact your Medtronic or Vitatron representative. If there is insulation
damage to the power cord or accessory cables or if any of the wall or equipment plugs are
damaged, replace the part and dispose of it according to local regulations or return the part
to Medtronic.
Electrode quality – Use of high-quality silver/silver chloride (Ag/AgCl) electrodes can
minimize the occurrence of small DC voltages that can block the ECG signal. Use electrodes
that are fresh and from the same box. Prepare the patient’s skin according to the directions
provided with the electrodes.
Avoid damage from programming head – Keep the programming head away from any
device or material that will be damaged by the magnetic field, including magnetic media,
watches, and other electronic devices.
Product and packaging labels and information – If labels or information appear to be
missing from the product or packaging, contact your local Medtronic representative at the
address and telephone number located on the back cover of this document.
1.6.1 Environmental precautions
To ensure safe and effective operation, use the device with care to avoid damage to the
programmer from environmental factors that may impair its function. Care is exercised in
design and manufacturing to minimize damage to devices under normal use. However,
electronic devices are susceptible to many environmental stresses including, but not limited
to, the following examples.
●
The unit is designed to be used indoors in a clinic or hospital.
●
The unit should not be dropped or mishandled in such a manner as to cause physical
damage to the unit. This may impair device function. Even if the unit works immediately
after being dropped, operational damage may have occurred that may not be observed
until some future time.
●
Fluid should not be spilled on the unit. Even though care is exercised in design and
manufacture of the unit to minimize leakage, fluid incursion may occur, which could
impair functioning of the unit.
●
The programmer may be affected by electrostatic discharge (ESD). In an environment
likely to cause ESD, such as a carpeted floor, discharge any charge collected on your
body before touching the device.
●
Printers and other connected office equipment should be placed at least 1.5 m (5 ft) from
the patient environment.
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●
Electrically-operated medical devices, such as the programmer require special care (in
terms of electromagnetic compatibility) when being installed. Refer to the
accompanying insert: Electromagnetic Compatibility Declaration.
●
Do not open the device. The programmer is constructed to minimize risk from
environmental factors. Opening the unit may make the unit susceptible to environmental
factors and may expose the patient or user to hazardous voltage or current.
●
Rapid temperature changes may affect proper operation. Always allow the temperature
to stabilize in the environment in which the device is used before using the device.
●
Prolonged storage or operation of the device in high humidity may affect proper
operation.
If there is any concern that damage has occurred, the unit should be returned to Medtronic
or Vitatron for inspection and any needed repair.
Besides these listed examples, various other environmental factors may impair proper
performance of the unit in the hospital setting. Always use good health management
practices to prevent environmental damage to the unit.
1.7 Declaration of Conformity
Medtronic declares that this product is in conformity with the essential requirements of
Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive
90/385/EEC on Active Implantable Medical Devices (AIMD).
For additional information, contact Medtronic or Vitatron at the telephone numbers and
addresses provided on the back cover.
1.8 Regulatory compliance
1.8.1 Industry Canada
ID:3408D-MICS
Operation is subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including interference that
may cause undesired operation of the device.
This device may not interfere with stations operating in the 400.150-406.000 MHz band in
the meteorological aids, meteorological-satellite, and earth exploration-satellite services
and must accept any interference received, including interference that may cause undesired
operation.
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1.8.2 Australia/New Zealand
The device fully complies with Australian Communications and Media Authority (ACMA) and
the New Zealand Ministry of Economic Development Radio Spectrum Management
standards. The C-tick symbol indicates that the product complies with the applicable
EMC/Radio standard for radio communications products.
1.8.3 US Federal Communications Commission (FCC)
FCC ID:LF5MICS (for programmer)
FCC ID:LF59767 (for programming head)
1.8.4 The following provision applies to the low frequency communications
system in the device:
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. The user is cautioned that changes or modifications not expressly approved by
the party responsible for compliance could void the user’s authority to operate the
equipment.
1.8.5 The following provision applies to the UHF communications system in
the device:
This transmitter is authorized by rule under the Medical Device Radio Communications
Service (47 C.F.R. Part 95) and must not cause harmful interference to stations operating in
the 400.150 - 406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers
used to communicate weather data), the Meteorological Satellite, or the Earth Exploration
Satellite Services and must accept interference that may be caused by such aids, including
interference that may cause undesired operation. This transmitter shall be used only in
accordance with the FCC Rules governing the Medical Device Radio Communications
Service. Analog and digital voice communications are prohibited. Although this transmitter
has been approved by the Federal Communications Commission, there is no guarantee that
it will not receive interference or that any particular transmission from this transmitter will be
free from interference.
1.9 Programmer functions
The following list summarizes some of the programmer functions. Specific functions depend
on the implantable device model being programmed or monitored and the software installed.
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1.9.1 Programming functions:
●
Permanent and temporary adjustment of parameter values.
●
Selection of nominal parameter values established by Medtronic, Vitatron or by the user.
●
Emergency buttons for VVI pacing.
1.9.2 Telemetry functions:
●
Automatic detection of the device model, and automatic application start-up, if the
programming head is in proper position when the programmer is turned on.
●
Automatic confirmation of a programmed change.
●
Reporting of currently programmed parameter values in effect and battery status of the
implanted device.
●
Reporting of real-time measurements of implantable device operating parameters such
as battery voltage, output energy, etc.
●
Display and printout of Marker Channel telemetry to simplify EGM analysis.
●
Display and printout of an atrial and/or ventricular intracardiac electrogram (EGM) taken
from the electrodes of the implantable device lead system.
1.9.3 ECG and other diagnostic functions:
●
ECG window on programming and telemetry data screens provides a continuous view
of the patient’s ECG.
●
Full-window ECG display including a freeze option and an amplitude adjustment feature;
ECG display includes Marker Channel telemetry, EGM waveforms, or both when
available.
●
Continuous multi-channel recording (ECG and Marker Channel telemetry or ECG and
EGM, for example).
●
Stimulation threshold test functions.
●
Direct measurement of pulse rate, AV interval, and pulse width.
●
Temporary implantable device inhibition.
●
Printout of programmed and measured information for permanent record.
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1.9.4 Software update function:
●
Automated software updates using a network connection, depending on the hardware
configuration. This connection allows the programmer to program new devices and to
provide new features as they become available.
●
Updates available from Medtronic personnel.
●
Clinical software applications that have Uninstall Software capability may be removed
using the programmer desktop.
1.10 Security features of the programmer
Good security practices are needed to protect patient data and the integrity of any
network-connected product. The programmer incorporates features that facilitate
management of security. These features work in conjunction with the security practices of
hospitals and clinics to provide safe and secure operation of the programmer and protect the
attached network.
1.10.1 How the programmer promotes security
All installed software has been approved by Medtronic. It is not possible to install general
purpose software on the programmer. Controlling installed software minimizes the potential
for vulnerabilities. Internal software that runs the programmer is locked from change. Every
time the programmer is started, a clean version of the installed software is used.
The length of time that patient data can be stored on the programmer is limited. When patient
data is removed from the programmer, it is completely erased so that it is no longer
recoverable.
The programmer limits how it communicates on a network. When communicating on a
network, the programmer uses industry-accepted protocols for authenticating servers and
encrypting transmitted data. Only required network connections are open and they are only
open when being used. Network communications are originated by the programmer.
Unauthorized software is not permitted to originate communications with the programmer.
Unsupported hardware, including unsupported USB devices, is ignored by the programmer
and is not accessed.
Medtronic continues to work with its partners to analyze emerging threats and evaluate
potential impact on the programmer.
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1.10.2 What hospitals and clinics can do to promote the security of
programmers
Maintain good physical controls over the programmer. Having a secure physical
environment prevents access to the internals of the programmer.
Only connect the programmer to managed, secure networks.
Update the software on the programmer when Medtronic updates are available.
1.10.3 What to do if you suspect the programmer has been compromised
If you believe that the programmer has been compromised by a security threat, turn off the
programmer, disconnect it from the network, then restart the system. Discontinue use of the
programmer if it does not behave as expected. Contact your Medtronic or Vitatron
representative for further assistance.
1.11 Software requirements
The programmer requires software from Medtronic and Vitatron to operate. Once installed,
the software remains on the programmer hard drive.
Medtronic and Vitatron periodically update the software to add functions to the programmer.
The programmer will not operate properly without the appropriate software installed. If the
programmer does not operate properly, check the version of software that is loaded on the
programmer, and update it if necessary.
1.12 Obtain technical manuals
Medtronic technical manuals, including the manual you are reading, are available from the
Medtronic Manual Library website listed on the back cover of this manual. The Medtronic
Manual Library website offers real-time access to the latest versions of Medtronic technical
manuals. Technical manuals can be viewed online, downloaded for viewing or printing, or
ordered from the website.
New manuals are added to this site regularly. If you do not find the technical manual you want,
contact your Medtronic or Vitatron representative.
Printed copies of technical manuals can be ordered. Refer the Medtronic Manual Library
website for more information.
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1.12.1 Access the Medtronic Manual Library website
To access the Medtronic Manual Library website and locate technical manuals, do the
following:
1. Point your browser to the address listed on the back cover of this manual.
2. Select the United States.
3. Follow the instructions on the Medtronic Manual Library website to locate, view, print, or
order technical manuals.
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2 Set up the programmer
2.1 System components
Figure 1. Programmer components - front view
1 Telephone cord (not supplied)
2 Emergency VVI button
3 Microphone jack
4 Display screen
5 Headphone jack
6 Power cord
7 Printer paper
8 Printer controls
9 Keyboard cover
10 Keyboard
11 Disk drive, PC card cover
12 Reference guide
13 Programming head (ordered separately)
14 Touch pen
15 Electrode leads
16 ECG cable with plug
17 Ethernet cable (not supplied)
Note: Only accessories approved by the manufacturer should be used.
Display screen – Display can be positioned smoothly from closed to nearly horizontal.
Programming options are selected on the screen with the touch pen.
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Emergency VVI button – Used to deliver bradycardia VVI operation.
Microphone jack – Intended for future use.
Headphone jack – Intended for future use.
Keyboard cover – Slides forward to protect the keyboard.
Keyboard – Used to enter information.
Printer controls – Select paper speeds of 12.5, 25, or 50 mm/s. Push a button once to
select printing speed. Push it again to stop printing. The Paper Advance button allows the
user to align the paper properly.
Telephone cord – Connects the programmer modem to a telephone jack. The telephone
cord must be 26 wire gauge minimum. (Not supplied by Medtronic.)
Ethernet cable – Used to connect the programmer to the clinic’s network. The Ethernet
cable must be Category 5 or better. (Not supplied by Medtronic.)
Printer paper – Paper for the internal printer.
Programming head – Provides the communication link between the programmer and the
patient’s implantable device. The programming head contains a strong permanent magnet,
radio-frequency (RF) transmitter and receiver, and light array. It must be held over the
implantable device during a program or interrogate operation. (Ordered separately; not
supplied with the programmer.)
Touch pen – Used to select options on the display screen. Predetermined options are
selected by applying the pen to the screen.
Electrode leads/ECG cable – Connects the programmer to skin electrodes on the patient
for ECG and measurement functions requiring surface detection of cardiac and implantable
device signals. Five color-coded lead wires connect the cable to standard, disposable skin
electrodes applied to the patient. (Not supplied by Medtronic.)
Note: If you are using a five-lead cable with a plug, the plug can be removed for five-lead
ECG applications.
Reference guide – Programmer Reference Guide, provides information about setting up
the programmer and between session features.
Disk drive, PC card cover – Provides access to the disk drive and the PC card. If applicable
to your programmer hardware, also provides access to USB port(s) and either Integrated
Ethernet or parallel connector.
Power cord – Connects the programmer to an AC power outlet.
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Figure 2. Front connectors (keyboard turned up)
1 Programming head (yellow marker)
2 Analog Input/Output (green marker)
3 ECG cable (black or blue marker)
Programming head – The programming head connector has a yellow marker.
Analog Input/Output – Allows an external monitor or recorder to be connected to the
programmer. This connector has a green marker.
ECG cable – Connects the ECG cable to the programmer. This connector has a black or
blue marker.
Figure 3. Left view
1 ON/OFF switch
2 Cooling fan
3 Expansion slot (shown with Analyzer
installed)
4 Printer
ON/OFF switch – Controls power (AC) to the programmer. Once the programmer is turned
off, wait 2 seconds before turning it on again.
Cooling fan – Internal fan provides continuous airflow to prevent the internal circuitry from
overheating.
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Expansion slot – Allows for additional features to be added, such as the Analyzer that is
available as an option.
Printer – Integral thermal printer with text and graphic output capabilities. According to the
selected function, the printer provides data reports or it can print out a continuous ECG with
accompanying Marker Channel telemetry, EGM, or both when available.
Figure 4. Right view
1 Disk drive, PC card cover
2 Infrared window
Disk drive, PC card cover – Provides access to the disk drive and the PC card. If applicable
to your programmer hardware, also provides access to USB port(s) and either Integrated
Ethernet or parallel connector.
Infrared window – Intended for future use.
Figure 5. Disk drive, with parallel connector, PC card cover open
1 PC card slot
2 Parallel connector
3 Disk drive
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Figure 6. Disk drive, with USB port, PC card cover open
1 PC card slot
2 Disk drive
3 Integrated Ethernet
4 USB port
PC card slot – There are different types of PC cards that can be plugged into the PC card
slot:
●
The Modem card.
●
The Combination Ethernet/Modem Network card, referred to as the combo card.
These PC cards can be used to connect to the Software Distribution Network or to connect
the programmer to a consultant’s computer.
Warning: When using a modem or combo card, make sure that the telecom voltage does not
exceed 125 V. Excessive voltage may damage the programmer.
Parallel connector – Allows a printer to be connected to the programmer.
Disk drive – Accommodates a 90 mm formatted diskette that is IBM-compatible.
Integrated Ethernet – Allows the programmer to connect to the Software Distribution
Network and the Paceart data management system using an Ethernet connection.
USB port(s) – Allows installation of software, software updates, and future device
application installations. The USB port can also be used to connect to a USB printer, a USB
flash drive, or a USB network adapter (contact a Medtronic service representative).
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Figure 7. Back view (power cord door open)
1 USB port(s)
3 Power cord
2 VGA output port
VGA output port – Allows porting the screen image of the programmer to an external VGA
monitor or for conversion of the output signal to NTSC/PAL format for presentation on a
television monitor.
Power cord – Connects the programmer to an AC power outlet.
2.2 Basic setup
Before setting up the programmer, select a sturdy location for it without blocking the air vents
on the right and left sides. The programmer uses a power cord, so the location must be near
an AC outlet.
This section describes how to:
●
Position the display
●
Connect the ECG cable
●
Connect the programming head
●
Connect the power cord
●
Connect the telephone line
●
Connect the Ethernet cable
●
Turn on the programmer
●
Troubleshoot potential interference
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2.2.1 Position the display
1. Press inward on the two buttons on each end of the handle.
2. Lift the display
3. Place it at a comfortable viewing angle.
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2.2.2 Connect the ECG cable
1. Slide the keyboard cover all the way back. Press the latch and flip up the keyboard.
2. Line up the arrow on the ECG cable with the red dot on the ECG connector.
3. Plug the cable into the connector with the black or blue marker on the right.
4. Flip down the keyboard, making sure that the cable passes through the notch on the
right or left side.
2.2.3 About the ECG cable
The Medtronic Model 2090 EC/ECL ECG cable and lead wires connect the programmer to
skin electrodes for ECG and measurement functions requiring surface detection of cardiac
and implantable device signals.
The ECG cable is designed for use with five lead wires. However, some physicians prefer to
use only four lead wires. If four lead wires are used, insert the chest ECG plug into the middle
cable port of the ECG cable.
Note: Improper insertion of the cable plug may damage the connector pins.
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Cautions:
●
Upon opening the package, if the ECG cable appears damaged, do not use it. Contact
your local Medtronic or Vitatron representative.
●
Do not pull on the insulated cable wire to disconnect the cable. Tension on the insulated
cable wire may result in damage to the cable.
2.2.4 Connect the programming head
1. Slide the keyboard cover all the way back. Press the latch and flip up the keyboard.
2. Line up the red dots on the programming head cable and the programming head
connector.
3. Plug the cable into the programming head connector with the yellow marker on the left.
4. Flip down the keyboard, making sure that the cable passes through the notch on the
right or left side.
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2.2.5 Connect the power cord
1. Open the back cover by pressing both latches.
2. Plug the power cord into the programmer.
3. Plug the power cord into AC power outlet. The programmer automatically adjusts to the
available line power.
4. Make sure the power cord passes through the notch on the left side and close the cover.
2.2.6 Connect the telephone line
1. Locate the disk drive/PC card cover on the right side of the programmer and flip down
the cover.
2. Connect the telephone line to the RJ-11 connector on the modem card or combo card.
(The combo card is shown.)
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