Medtronic 29901 User Manual
M945141A001_fc.fm 4/27/12 10:00 am
DRAFT VERSION
May 22, 2012
7" x 9" (178 mm x 229 mm)
CARELINK ENCORETM 29901
Programmer for Medtronic and Vitatron Devices
Medtronic Confidential
CRDMRef_R1.1
M945141A001 Rev B Refer to the “Reference manual” category in doc#163256 for Printing
Reference Manual
29901/SW028:
Instructions.
VSH02:
M945141A001_fc.fm 4/27/12 10:00 am
7" x 9" (178 mm x 229 mm)
Medtronic Confidential
CRDMRef_R1.1
M945141A001 Rev B Refer to the “Reference manual” category in doc#163256 for Printing
Instructions.
Printing instructions: doc#163256; refer to 'Reference manuals' row in the applicable table. 501346-089
CARELINK ENCORE™ 29901
Reference Manual
A guide for setting up and using the CareLink Encore 29901 Programmer.
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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.
CareLink, CareLink Encore, Marker Channel, Medtronic, Paceart, SessionSync,
Vitatron
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Contents
1 Introduction to the programmer ....................................... 8
1.1 Explanation of packaging and product symbols .......................... 8
1.2 About this guide .................................................... 11
1.3 Description ........................................................ 11
1.4 Intended use ....................................................... 12
1.5 Warnings .......................................................... 12
1.6 Precautions ........................................................ 15
1.7 Declaration of Conformity ............................................ 17
1.8 Regulatory compliance .............................................. 17
1.9 Programmer functions ............................................... 18
1.10 Security features of the programmer ................................... 19
1.11 Software requirements ............................................... 20
1.12 Compatible components ............................................. 20
1.13 Obtain technical manuals ............................................ 21
2 Set up the programmer .............................................. 22
2.1 System components ................................................ 22
2.2 Programmer button panel ............................................ 25
2.3 Basic setup ........................................................ 26
2.4 Charge the battery .................................................. 32
2.5 Use external printers ................................................ 35
3 Configure the programmer ........................................... 40
3.1 Display screen features .............................................. 40
3.2 About the Between Patient Sessions tool palette ........................ 43
3.3 Change the language setting ......................................... 44
3.4 Use the on-screen keyboard .......................................... 45
3.5 View and update programmer location and hardware information .......... 45
3.6 Adjust programmer time and date ..................................... 46
3.7 Select audible tones ................................................. 47
3.8 Check the software version ........................................... 48
3.9 Select other software ................................................ 49
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3.10 Remove other software applications ................................... 49
3.11 Improve the detection of pacing artifacts ............................... 50
3.12 Start the Demonstrations option ....................................... 50
3.13 Configure network using the Network Configuration window ............... 51
4 Update programmer software using the Software Distribution
Network ........................................................... 54
4.1 The Software Distribution Network .................................... 54
4.2 Connect to the SDN using a wired network connection ................... 54
4.3 Connect to the SDN using a wireless network connection ................. 59
5 Conduct a patient session ........................................... 62
5.1 Prepare for a patient session ......................................... 62
5.2 Initiate a patient session ............................................. 69
5.3 Electronic Strip Chart (eStrip) recorder ................................. 73
5.4 Emergency VVI button ............................................... 76
5.5 End a patient session ................................................ 77
5.6 Store components .................................................. 78
6 Manage session data and reports ..................................... 79
6.1 Session data ....................................................... 79
6.2 Reports ............................................................ 79
6.3 Save to a PDF file ................................................... 79
6.4 Save to USB ....................................................... 80
6.5 View reports that are saved to media .................................. 81
6.6 View reports on the programmer using PDF Viewer ...................... 82
6.7 Viewing and printing PDF files on a computer ........................... 82
6.8 Manage patient data privacy .......................................... 83
6.9 Set the interval for report deletion ..................................... 86
7 SessionSync (Optional) .............................................. 88
7.1 About SessionSync ................................................. 88
7.2 Enable and disable SessionSync ...................................... 88
7.3 SessionSync Status icon ............................................. 89
7.4 Use Automatic SessionSync .......................................... 90
7.5 Use Manual SessionSync for supported devices ........................ 91
7.6 SessionSync error message descriptions ............................... 91
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7.7 View SessionSync Status screen ...................................... 92
7.8 Update SessionSync status .......................................... 92
8 Service the programmer ............................................. 94
8.1 Clean the system components ........................................ 94
8.2 Sterilize the programming head, ECG cable, and lead wires ............... 94
8.3 Programmer specifications ........................................... 96
8.4 Special notice ...................................................... 98
8.5 Medtronic limited warranty ........................................... 99
A End-user license agreement ......................................... 100
A.1 End-user license agreement (EULA) terms ............................ 100
Index ................................................................... 105
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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.
Caution
Consult instructions for use
The product complies with both Canadian and U.S. requirements for meeting UL safety standards.
System meets the applicable Canadian [C22.2-601.1-M90 (R2001)
CAN/CSA C22.2 No. 60601-1-08] and US (UL 60601-1:2003) electrical
safety standard requirements.
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with European Directive AIMD 90/385/EEC (NB
0123). (Applies to Medtronic hardware and software only.)
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with European Directive AIMD 90/385/EEC (NB
0344). (Applies to Vitatron desktop software only.)
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with the essential requirements of R&TTE Directive 1999/5/EC (NB 0984). (Applies to Bluetooth only.)
This product conforms to IP21. There are no openings that allow the user
to insert a finger or similar sized objects. The product is resistant to dripping
water or vertically falling drops.
Use only with specified power supply.
Class II ME Equipment
Type BF applied part
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Temperature limitation
Humidity limitation
RF transmitter
Notice of proper disposal.
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.
Caution: Strong magnet
Network connection port
USB port
DC input
ExpressCard
Battery
VGA monitor
Manufacturer/Date of Manufacture
Authorized representative in the European community
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Reorder number
Serial number
Lot number
Humidity limitation
Package contents
Programmer, software installed
Power cord
Product documentation
Accessories
Programmer
Stylus / tether
Programming head
Power supply
Power cord
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Battery
China RoHS
This product contains lead (Pb). 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.
Turn the page
Store programming head
Do not wrap cord behind head
Do not wrap cord around head
1.2 About this guide
This guide describes the features and functions of the CareLink Encore 29901 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
The CareLink Encore 29901 Programmer is a portable, line-powered (AC) or
battery-powered microprocessor-based system with software to interrogate and program
Medtronic and Vitatron implantable devices. Other features include:
●
Automated software updates using a wireless or local area network (LAN) connection.
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.
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1.4 Intended use
The programmer is intended to be used to interrogate and program Medtronic and Vitatron
implantable devices.
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.
Battery charging – Use the programmer for charging batteries by installing the battery and
connecting the power supply. Unapproved charging equipment may damage the battery or
cause excessive heating, battery case rupture, or ignition of the battery cells. Use of a
damaged battery may damage equipment or cause user or patient injury.
Battery disposal – Do not dispose of batteries in fire, in order to avoid the risk of explosion.
Battery exposure – Exposing the battery to cold temperatures may result in a loss of
performance and shortened battery service life. Use of a damaged battery may cause injury,
damage equipment, or impact user or patient safety.
Battery handling – Do not puncture batteries. Do not disassemble batteries as this can
generate a gas that may irritate the throat and lungs. If the battery is opened, lithium in the
battery may react with moisture and generate heat or fire, which could result in injury.
Battery overheating – Do not store the programmer battery in direct sunlight, inside a car,
or in an enclosed space in extremely hot weather. Overheating the battery may result in a
loss of performance and shortened battery service life. The battery contains built-in thermal
protection circuitry that prevents the battery from charging when hot. Excessive heating of
the battery may cause battery case rupture or ignition of the battery cells.
Battery replacement – If you receive a message on the programmer to replace the battery,
you need to replace the battery with a new battery. Use of a failed battery will reduce
programmer operating time and may cause user or patient injury. For more information, see
Section 2.4.
Connection of external devices – Additional equipment connected to medical electrical
equipment must comply with the respective IEC or ISO standards (for example, IEC 60950
for data processing equipment). All configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC
60601-1, respectively). Anyone connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible that the system
complies with the requirements for medical electrical systems. Local laws take priority over
the above mentioned requirements. If in doubt, consult your local Medtronic representative
or the technical service department.
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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.
Electric shock risk – Do not simultaneously touch the patient and any metal parts of the
programmer, such as the USB port or the power connector, as voltage may be present.
Application of voltage to the patient may impact user or patient safety.
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.
High sound pressure levels – The programmer speaker may emit alert tones at high
sound pressure levels. Consider speaker position when setting up the programmer, and
dismiss alerts as soon as possible, in order to avoid hearing damage. Exposure to high
sound pressure levels may damage hearing and impact patient health.
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.
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.
Internal RTC battery replacement – The real-time clock (RTC) battery, located inside the
programmer on a circuit board, is not replaceable by the user. The battery needs
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replacement if the time-of-day clock cannot keep time. Return the programmer to Medtronic
for replacement. Use of damaged equipment may impact user or patient safety.
Light-emitting diode (LED) radiation – This device contains Class 1M LEDs. To avoid
eye injury, do not view LEDs directly with optical instruments or magnifiers.
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.
Programmer ventilation – Ensure that the fan is running and programmer ventilation
openings are not blocked, in order to prevent overheating. Overheating may cause
equipment damage or user or patient safety.
Supply mains with protective earth – To avoid the risk of electric shock, connect the
power supply only to a hospital-grade supply mains receptacle which has a protective earth.
If the integrity of the supply mains protective earth is in doubt, operate the device using the
charged internal battery only.
Use of approved components – Use the specified, Medtronic-supplied power cord,
power supply, battery, and components only. The battery is a custom component designed
to be used solely in the programmer; replace with and use only the battery supplied by
Medtronic. Use of unapproved components may reduce device effectiveness or impact user
or patient safety.
Use of unapproved ports and connections – Do not connect unapproved or
unsupported equipment or components, such as a docking station, to the programmer. Use
of unapproved components may damage equipment or impact user or patient safety.
Use of unapproved power supply – Use only the Medtronic-supplied power supply model
26907 (APS100EM-190530) with the programmer. Use of an unapproved power supply
may damage equipment or impact user or patient safety.
Use of wireless devices – The programmer incorporates radio-frequency (RF)
communications components which may affect other devices and equipment in the medical
environment. The use of wireless devices in the medical environment must be evaluated
and authorized by the responsible organization. RF interference may affect device
performance.
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1.6 Precautions
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.
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.
Finger injury – Do not place fingers in the hinge area when opening or closing the stand.
Do not place fingers near the storage doos when opening or closing the storage doors. A
painful pinch may result.
Programmer and power cord positioning – Position the programmer and power cord so
that the power cord can be easily accessed and disconnected. If it is necessary to remove
the programmer from the AC mains, the power cord is the power disconnect at the mains
outlet.
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Connection or disconnection of programming head – Do not connect or disconnect
the programming head while the programmer power is on. Disconnecting the programming
head causes an error that requires the programmer to be shut down and restarted.
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.
●
The programmer should be placed on a table or other hard surface and positioned to
avoid contact with the physician or patient; it is not intended to be used while supported
by or in contact with the physician or patient.
●
The programmer should maintain a distance of at least 20 cm away from patients and
clinicians when the programmer is using Wi-FI or Bluetooth radios.
●
Printers and other connected office equipment should be placed at least 1.5 m from the
patient environment.
●
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.
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●
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 US Federal Communications Commission (FCC)
FCC ID:LF529901 (for programmer and programming head)
1.8.2 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.
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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.
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 button 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, battery status of the
implanted device, saved implantable system information, and patient status
information.
●
Display and save as a PDF file an atrial and/or ventricular intracardiac electrogram
(EGM) taken from the electrodes of the implantable device lead system or Marker
Channel telemetry.
1.9.3 ECG functions:
●
Live Rhythm Monitor window on programming and telemetry data screens provides a
continuous view of the patient’s ECG.
●
Full-window Live Rhythm display including a freeze option and an amplitude adjustment
feature; Live Rhythm display includes Marker Channel telemetry, EGM waveforms, or
both when available.
●
Continuous multi-channel storage.
●
Stimulation threshold test functions.
●
Direct measurement of pulse rate, AV interval, and pulse width from the desktop.
Warning: Do not use the programmer ECG display for recording or diagnosis. Use a
separate ECG device if recording or diagnostic ECG capabilities are required.
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1.9.4 Software update function:
●
Automated software updates using a wireless or local area network (LAN) connection.
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.
Patient data is encrypted. The length of time that patient data can be stored on the
programmer is limited. The programmer limits patient data stored on the programmer by
deleting it after at most 14 days. 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. 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.
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 Compatible components
The following compatible components are available for the programmer:
●
Battery 26902
●
EC 2090 ECG Cables, Electrode Lead Wires, and Plug
●
EC ECL 2090 ECG Cables, Electrode Lead Wires, and Plug
●
Power Cord 26906
●
Power Supply 26907 (APS100EM-190530)
●
Programming Head 26901
●
Stylus and Tether 26905
Contact your local Medtronic representative to order them.
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The following components are available as repair parts during authorized service only:
●
Articulating Stand 26909
●
Storage Doors 26908
1.13 Obtain technical manuals
Medtronic technical manuals, including the manual you are reading, are available in a
number of different formats from the Medtronic eManuals website listed on the back cover
of this manual. The website offers real-time access to the latest version of manuals 24 hours
per day, seven days per week. Manuals can be viewed online, downloaded for viewing or
printing, or ordered from the website.
All manuals are available online in English. Most manuals are also available in additional
languages in online, CD-ROM, or paper format. New manuals are added to this site
regularly. If you do not find the manual you want, contact your Medtronic or Vitatron
representative.
Your order for CD-ROM or printed versions of manuals ships from our facility within 24 hours
and should reach you within 3 business days. If you need a copy before the shipment arrives,
download the manual and print it, or contact your Medtronic or Vitatron representative.
1.13.1 Access the eManuals website
1. Point your browser to the address listed on the back cover of this manual.
2. Select location and language, and click [Continue].
3. Select one or more manual languages, and click [Continue].
To see lists of CRDM manuals, click the desired category on the left of the screen. You can
also search for manuals using a product name or model number.
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2 Set up the programmer
2.1 System components
Figure 1. Programmer components - front view
1 Programming head
2 Button panel
3 Stylus and Tether
4 Product documentation
5 Ethernet cable (not supplied)
6 Display screen
7 Battery
8 Power cord
9 Power supply
10 Electrode leads (not supplied)
11 ECG cable with plug (not supplied)
Warning: Use only the specified, Medtronic-supplied power cord, power supply, and
components. Use of unapproved components may reduce device effectiveness or impact
patient health.
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.
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Display screen – Display can be positioned horizontally, vertically, or at an angle.
Programming options are selected on the screen with the stylus.
Stylus – Used to select options on the display screen. Predetermined options are selected
by applying the stylus to the screen.
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.)
Power cord – Connects the power supply to an AC power outlet.
Power supply – Connects the programmer to the power cord.
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. Four color-coded lead wires connect the cable to standard, disposable skin
electrodes applied to the patient. (The electrode leads/ECG cables are optional.)
Figure 2. Right view
1 ExpressCard slot
2 Battery cover
ExpressCard slot – Intended for future use.
Battery cover – Covers the battery compartment. Push the cover forward and slide it out
to insert or remove the battery.
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Figure 3. Left view
1 USB ports
2 VGA output port
3 Integrated Ethernet
4 Power input
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 or a
USB flash drive.
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.
Integrated Ethernet – Allows the programmer to connect to the Software Distribution
Network and the Paceart data management system using an Ethernet connection.
Power input – Used to connect the programmer to an AC power outlet using the power
supply and power cord.
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Figure 4. Back view (doors open)
1 Programming head connector
2 ECG cable connector
2.2 Programmer button panel
Figure 5. Programmer button panel
The programmer button panel contains these buttons and indicators:
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Table 1. Buttons and indicators on the programmer button panel
Button or indicator Name Function
Electronic Strip Chart
(eStrip) button
Emergency VVI button Provides immediate access for emergency VVI
RFID button Intended for future use.
Bluetooth button Used to enable or disable Bluetooth power.
Wi-Fi button Used to enable or disable Wi-Fi power.
Used to insert a highlight into the recorded Electronic Strip Chart (eStrip) waveform data.
pacing during a session.
Battery Status indicator Provides information about the status of the bat-
tery.
Battery Charge indicator Provides information about the charge of the bat-
tery.
Power button Turns on and turns off the programmer.
2.3 Basic setup
Before setting up the programmer, select a sturdy location for it without blocking the air vents
on the back. The programmer uses an AC power supply and has a backup battery. To use
the power supply, the location of the programmer must be near a hospital-grade supply
mains receptacle which has a protective earth.
This section describes how to:
●
Position the programmer
●
Connect the power supply
●
Install the battery
●
Connect the programming head
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Connect the ECG cable
●
Turn on the programmer
●
Troubleshoot potential interference
2.3.1 Position the programmer
The programmer can be positioned horizontally or at an angle.
1. To position the programmer at an angle, pull out the stand on the rear of the
programmer.
2. Place it at a comfortable viewing angle.
Caution: Do not place fingers in the hinge area when opening or closing the stand. A painful
pinch may result.
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2.3.2 Connect the power supply
1. Open the power input cover on the lower left side of the programmer.
2. Plug the power supply into the programmer.
3. Plug the power cord into the power supply.
4. Position the programmer and power cord so that the power cord can be easily
accessed and disconnected.
5. Plug the power cord into the AC power outlet (AC mains).
Note: If it is necessary to remove the programmer from the AC power outlet (AC mains),
the power cord is the power disconnect at the mains outlet.
Warnings:
●
To avoid the risk of electric shock, connect the power supply only to a hospital-grade
supply mains receptacle that has a protective earth. If the integrity of the supply mains
protective earth is in doubt, operate the device using the charged internal battery only.
●
Use only the specified, Medtronic-supplied power cord, power supply, and
components. Use of unapproved components may reduce device effectiveness or
impact patient health.
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2.3.3 Install the battery
1. Open the battery door on the lower right side of the programmer by pressing forward
on the battery door recess and flipping the door to the left.
2. Slide the battery in until you hear it click into position. The battery is kept in position by
a hook located on the bottom of the opening.
3. Close the battery door.
Notes:
●
The battery is supplied partially charged. After installing a new or replacement battery,
connect the power supply and charge the battery for 2 hours before operating the
programmer on battery power.
●
If the programmer is on, turn the programmer off before installing or removing the
battery.
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2.3.4 Connect the programming head
1. Open the door on the left rear of the programmer.
2. Line up the black arrows on the programming head cable and the programming head
connector.
3. Plug the cable into the programming head connector with the yellow marker.
4. Close the door, making sure the cable passes through the notch on the bottom of the
door.
Warning: Do not connect or disconnect the programming head while the programmer
power is on. Disconnecting the programming head causes an error that requires the
programmer to be shut down and restarted.
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