Professional Documents
Culture Documents
carelink_2090
carelink_2090
1
Explanation of packaging and product symbols 8
Warnings 11
Precautions 12
Declaration of Conformity 15
Regulatory compliance 15
Software requirements 17
Programmer functions 18
System components 20
Serial number
Temperature limitation
Off
On
RF transmitter
This symbol means that the device 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.
Battery
Diskette
USB port
Printer port
Microphone port
Headphones port
Manufacturer
Reorder number
Lot number
Humidity limitation
Package contents
Product documentation
Accessories
Warnings
Precautions
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 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, you should discharge any charge collected on
your body before touching the device.
■ Electrically-operated medical devices, such as the
Programmer require special care (in terms of EMC) 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.
■ 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.
Declaration of Conformity
Regulatory compliance
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.
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.
US Federal Communications Commission (FCC)
FCC ID:LF5MICS (for Programmer)
FCC ID:LF59767 (for Programming head)
Software requirements
Programmer functions
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.
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.
System components
Figure 1-1. Programmer components - front view
1
VVI
3
4
8
9 7 5 16
6
15
10
14
11
13
12
17
3
2
1
2 3 4
1 2
1 2
1 PC card slot
2 Parallel connector
3 Disk drive
4
2 3
1 PC card slot
2 Disk drive
3 Integrated Ethernet
4 USB port
3
1 2
1
2
4 3
7
6
1 Task bar 5 Task area
2 Status bar 6 Command bar
3 Live Rhythm Monitor window 7 Buttons
4 Waveform adjustment bars 8 Tool palette
Task bar
Status bar
Before selecting a model, the status bar has no information. For
specific information about the status bar, refer to the reference
guide for the implanted device. After model selection, the status
bar may include:
■ The present pacing mode.
■ Test condition status.
■ The device model.
1 Status bar
Task area
The portion of screen between the Live Rhythm Monitor window at
the top and the command bar at the bottom changes according to
the task or function you select.
Command bar
The bar at the bottom of the screen shows the command buttons
for automatically launching the proper software application and
displaying the Vitatron Select Model screen. For information on
what command buttons are available after selecting a model, see
the reference guide for the implanted device.
Buttons
Buttons like those shown below let you operate the Programmer
using the touch pen. You can “press” a button by touching it with
the tip of the touch pen.
1 Inactive button (indicated by a lighter color)
Tool palette
The collection of buttons and icons along the edge of the screen
is referred to as the “tool palette.” These are the controls you will
use to choose the task or function screen you want displayed. For
more information, see “About the between sessions tool palette”
on page 72. For information about the session tool palette, refer to
the reference guide for the implanted device.
2
Basic setup 32
Basic setup
Notes:
The Programmer will not operate without the appropriate software
installed. If the Programmer does not operate, check the version
of software that is loaded on the Programmer, and update it if
necessary.
The first time the Programmer is turned on following one of these
changes, the start-up will take 2 minutes:
■ When a new keyboard language is installed
■ When the keyboard is removed (the Programmer has been
previously turned ON with a keyboard)
■ When a keyboard has been added (the Programmer has been
previously turned ON without a keyboard)
■ When the PC card has been removed (the Programmer has
been previously turned ON with a PC card)
■ When a PC card has been added (the Programmer has been
previously turned ON without a PC card)
1
1 Analog Input/Output connector with green marker (under
the keyboard)
3
Prepare for a patient session 40
Store components 56
40 Chapter 3
Prepare for a patient session
Attach electrodes
Table 3-1.
N
VVI
Amber/Green
VVI
Emergency VVI
Button (Red)
Programmer checklist
Model identification
Because the Programmer collects and stores data on a
session-by-session basis, it is important to correctly start and end
each session.
The Programmer supports both a Medtronic and Vitatron desktop.
Whichever desktop is in use when the Programmer is powered
down, that same desktop will appear when the Programmer is
powered on. To switch from the Vitatron desktop to the Medtronic
desktop and vice versa, select the Vitatron/Medtronic switch
button that appears on the bottom of the screen.
There are two ways to begin a patient session:
■ Prior to turning on the Programmer, position the programming
head over the patient’s device. When you turn on the
Programmer, the Programmer will attempt to interrogate the
device. Depending on the device, either the software
application will be launched automatically or a message will
appear with further instructions.
■ After turning on the Programmer, position the programming
head over the patient’s device. During the first 5 minutes, the
Medtronic desktop will display the Find Patient screen.
Afterward, it displays the Select Model screen. The Vitatron
desktop displays the Select Model screen immediately. A
patient session can begin at either the Find Patient screen or
the Select Model screen. Follow the instructions on the screen
that displays.
Place the programming head over the patient’s device and hold it
steady. For most devices, the Programmer will identify the device
model and automatically start up the proper software application.
If a device cannot be automatically identified, the Programmer
displays a message at the top of the Find Patient screen. Perform
one of the following steps, depending on the message
instructions:
■ Select [Cancel] and manually select the software application
from the Select Model screen.
■ Select [Cancel] and then select the Vitatron/Medtronic switch
button to go to the Vitatron desktop.
■ If the message indicates that the needed software application
has not been installed, contact your Medtronic or Vitatron
representative.
When you want to end a patient session, you may save data to a
supported storage device or end the session without saving.
Please refer to the reference guide for the implanted device for
specific information on saving device data.
Store components
VVI
4
Reports 58
Session data 58
Save to diskette 59
Save to USB 59
Reports
Session data
4. From the list of printers, select the Save to PDF File option.
The report is saved to an attached USB flash drive, or to a
diskette, if one is present in the diskette drive and a USB flash
drive is not connected. Refer to “Saving to USB” for further
information.
Save to diskette
Refer to the reference guide for the implanted device for specific
information on saving and reading device data using a diskette.
The diskette drive is functional only when a USB flash drive is not
in use. Before using the diskette drive, ensure that a USB flash
drive is not connected to the Programmer.
When no USB flash drive is connected, the diskette indicator is
green to indicate that the diskette drive is available for use.
Inserting a diskette allows all session data and PDF file saving
operations to take place on the diskette.
Save to USB
Operation
A USB flash drive should be connected or disconnected while at
the Desktop or in a session. Connect a writable USB flash drive to
the Programmer using any available USB port. A slight delay may
occur while the USB flash drive is authorized. The USB indicator
on the task bar turns green to indicate that the USB flash drive is
available for use, and the diskette icon turns gray to indicate that
the diskette drive is not available.
5
Use external printers 64
Printer buttons 68
Printer compatibility
The Programmer is compatible with many printers. A list of
compatible printers can be accessed from the Print Queue screen.
Note: When programming a Vitatron device, refer to the
applicable Vitatron reference guide for information about the print
queue.
1. To connect a printer, locate the correct port. There is one USB port
located under the disk drive/PC card cover and two ports located
under the power cord door on the back of the Programmer.
2. Connect the printer cable to a USB port on the side or back of the
Programmer.
3. Connect the other end of the cable to the printer. Connect the
printer power cord to an outlet and turn the printer on. Make sure
that the printer has paper.
Note: Refer to the technical information provided with your printer
for information about connecting and operating the printer.
4. Turn the Programmer on and select the Print Queue icon.
Note: Be sure to select the correct printer driver from the options
listed when you select the Printer field on the Print Queue window.
You are now ready to use your Programmer with the connected
printer.
1. Press the latch on the top of the tray on the left side of the
Programmer. Slide the tray out. Flip the paper holder over
the end of the tray and remove any remaining paper.
Note: The tray may be taken out of the Programmer to make
removing any remaining paper easier. Press down on the
lever on the side of the tray toward the front of the
Programmer.
2. Remove the wrapping from a new flat pack of printer paper,
dispose of the cardboard and unfold the top sheet.
Note: The shiny side of each sheet of paper with two black
squares should be facing up as the paper is loaded into the
tray. The black squares must be positioned toward the front
of the Programmer.
3. Slide the paper pack toward the back of the tray. Flip the
paper holder over the paper pack.
4. Fold the top sheet of paper over the paper holder. Slide the
tray back into position.
Printer buttons
1
2
3
4
When you wish to tear off a printout, separate the paper strip at a
perforation. To tear the printout off at the printer, press Paper
Advance. This action advances the paper to the next perforation.
Grasp the printout near the printer, and pull.
Figure 5-2. Tearing off printouts
As the paper supply nears its end, a red stripe will appear along
the edge of the paper. At this point, a new paper pack should be
installed as previously described in this chapter. When the paper
supply runs out, the printer stops operating.
Note: The thermal paper used in this Programmer is intended for
immediate use. As the quality of thermal paper diminishes over
time, the image fades. Medtronic and Vitatron recommend that
you make photocopies for your files.
6
About the between sessions tool palette 72
Or,
If the Programmer is unable to complete deletion of files, it
displays a message stating that there was an error and that some
data may remain on the Programmer (Figure 6-9). Click Close.
Contact Medtronic Technical Support if the message recurs.
Figure 6-9. Error deleting files dialog box
Choose a language
Note: If the model that you require is not displayed, the software
to support that model is not currently loaded on the Programmer.
Contact your Medtronic or Vitatron representative.
Access demonstrations
1. Point your browser to the web site listed on the back cover of this
manual
2. Make location and language selections, and click OK.
3. To see lists of CRDM manuals, click on the desired category on the
left of the screen. You can also search for manuals using a product
name or model number.
7
Clean the system components 86
Replace a PC card 87
Programmer specifications 88
Special notice 91
Ethylene-oxide
Note: The programming head or ECG cable and lead wires must
be completely dry before being ethylene-oxide sterilized.
Gas plasma (programming head only STERRAD 100S gas plasma system)
Replace a PC card
Programmer specifications
Power requirement
Voltage 100 to 125 VAC nominal or
200 to 240 VAC nominal
Frequency 50/60 Hz nominal
Power 400 watts
Printer
Resolution 600 dots/25 mm horizontally for waveform
traces at print speeds through 25 mm/sec.,
400 dots/25 mm at 50 mm/sec.;
200 dots/25 mm vertically
Paper Type 110 mm wide, Thermal, Medtronic No. 6092
Waveform Recording 12.5, 25 or 50 mm/s
Speeds
Temperature limits
Operating 9.4 °C to 35 °C
Storage - 22 °C to 60 °C
Humidity limits
Operating 80%
Storage 95% at 35 °C
Modem card
Data Interface PCMCIA Release 2.1 compliant, 68-pin
connector
Analog Interface RJ-11 modular telephone connector
Data Modulation V.90/K56 flex up to 56 Kbps
Maintenance
Medtronic recommends that the user should test the Programmer
for operability and also visually inspect the Programmer and its
accessories (e.g., power cord, cables) prior to each use as
outlined in the section above.
Caution: 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, please replace the part and dispose of it according to
local regulations or return the part to Medtronic.
Safety checks
Safety checks require a functional test and electrical safety tests
once every two years. It is not necessary that technical and safety
inspections are performed by Medtronic or Vitatron personnel;
however, technical and safety inspections of the Programmer and
its accessories must be performed by persons, who, based on
their training, knowledge, and practical experience, are capable of
adequately performing such inspections and who do not require
instructions with regard to the technical and safety inspection.
Warning: If technical and safety inspection reveals a defect which
could harm the patient, clinicians, or third parties, the device
should not be used until it has been properly repaired. The
operator must immediately notify Medtronic or Vitatron of these
defects.
Special notice
D
date and time
setting 73
Declaration of Conformity 15
demonstrations option 81
A dimensions, programmer 89
AC power cord 26 disk drive 24
AC power input 26 diskette, saving to 59
ACMA 15 display screen
Adjust button 72 features of 27
Adobe settings 62
AHA coding E
electrodes 42 ECG
analog output cable 22, 23
connections 24 cable connections 33
artifact detection 79 diagnostics 19
Australia regulations 15 functions on the Programmer 19
Auto Identify electrocardiograms (ECG)
see Find Patient window, expanding 27
electrodes
B AHA coding 42
buttons attaching 42
Adjust 72 IEC coding 42
Auto Identify Emergency button 21, 49, 50
see Find Patient environmental precautions
description 30 disposal of Programmer 9
Emergency 49 while using Programmer 14
Find Patient 30, 54 Ethernet cable 21
Freeze 72 Ethernet/modem card
I (programming head) 48 see combo card
inactive 73 external components
P (programming head) 48 see components
Programmer 68 external devices, connecting 37
Emergency VVI 21
Vitatron/Medtronic switch 54 F
features
C Programmer 10
combo card 25 Federal Communications Commission (FCC) 15
connecting Ethernet cable 35 Find Patient button 54
connecting telephone line 35 Find Patient screen 52
replacing 87 Freeze button 72
specifications for 89, 90
components H
storing 55, 56 hardware information, programmer 81
concurrency 55
I P
I button (programming head) 48 P button (programming head) 48
icons Paper Advance button 68
Analyzer indicator/selector 28 paper supply, low 69
device indicator/selector 28 patient session, conducting 51
inactive 73 PC card
position head light array 28 see also combo card
Print Queue 72 see also modem
Programmer 72 replacing 87
Select Model 72 PDF, saving to 58
IEC coding pen
electrodes 42 using 43
Industry Canada 15 position head light 21
input/output ports 26 power cord
interference 13 storing 26
troubleshooting 37 precautions
environmental 14
L Programmer 12
live rhythm programmer modification 12
window 27, 29 print queue settings 75
location, programmer 81 printer
low paper supply 69 access 23
buttons 68
M
compatibility 64
manual-guided reset 62 connecting 65
manuals specifications 88
obtaining from website 84
Printing
Marker Channel telemetry 18, 37 tearing off printout 69
model (device) profile, programmer 81
selection screen 54
programmer
model numbers 81 components 20
modem dimensions 89
replacing 87
functions 18
specifications for 89 hardware information 81
monitor, connecting 37 location 81
N preferences 74
profile 81
New Zealand regulations 15
setting time and date 73
O specifications 88
ON/OFF switch 23, 36 tool palette 72
operating preferences 74 view or update serial numbers 81
operating temperature weight 89
programmer 89 programming head
other software buttons 48
option 83 determining the correct position 46
magnet 49
T
task bar 28
telemetry
functions 18
Marker Channel 18, 37
temperature limits
programmer 89
time and date
setting 73
Australia
Medtronic Australasia Pty Ltd
97 Waterloo Road
North Ryde, NSW 2113
Australia
Technical manuals:
www.medtronic.com/manuals
*M943414A001*
© Medtronic, Inc. 2011
M943414A001A
2011-04-05