CARELINK ENCORE Model 29901 Programmer Reference Manual Rev B

CARELINK ENCORE™ 29901 Reference Manual

A guide for setting up and using the CareLink Encore 29901 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. CareLink, CareLink Encore, Marker Channel, Medtronic, Paceart, SessionSync, Vitatron

Medtronic

CARELINK ENCORE™ 29901

Contents 1 Introduction to the programmer... 8 1.1 CE mark of conformity... 8 1.2 Explanation of packaging and product symbols... 8 1.3 About this guide... 12 1.4 Description... 12 1.5 Intended use... 13 1.6 Contraindications... 13 1.7 Warnings... 13 1.8 Precautions... 16 1.9 Declaration of Conformity... 18 1.10 Regulatory compliance... 19 1.11 Programmer functions... 19 1.12 Security features of the programmer... 21 1.13 Software requirements... 22 1.14 Compatible components... 22 1.15 Obtain technical manuals... 23 2 2.1 2.2 2.3 2.4 2.5

Set up the programmer... 24 System components... 24 Programmer button panel... 27 Basic setup... 28 Charge the battery... 35 Use external printers... 37

3 3.1 3.2 3.3 3.4 3.5 3.6 3.7

Configure the programmer... 42 Display screen features... 42 About the Between Patient Sessions tool palette... 45 Change the language setting... 46 Use the on-screen keyboard... 47 View and update programmer location and hardware information... 47 Adjust programmer time and date... 48 Select audible tones... 49

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3.8 3.9 3.10 3.11 3.12 3.13

Check the software version... Select other software... Remove other software applications... Improve the detection of pacing artifacts... Start the Demonstrations option... Configure network using the Network Configuration window...

4 4.1 4.2 4.3

Update programmer software using the Software Distribution Network... 56 The Software Distribution Network... 56 Connect to the SDN using a wired network connection... 56 Connect to the SDN using a wireless network connection... 61

5 5.1 5.2 5.3 5.4 5.5 5.6

Conduct a patient session... 64 Prepare for a patient session... 64 Initiate a patient session... 70 Electronic Strip Chart (eStrip) recorder... 74 Emergency VVI button... 78 End a patient session... 79 Store components... 79

6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9

Manage session data and reports... 80 Session data... 80 Reports... 80 Save to a PDF file... 80 Save to USB... 81 View reports that are saved to media... 82 View reports on the programmer using PDF Viewer... 83 Viewing and printing PDF files on a computer... 83 Manage patient data privacy... 84 Set the interval for report deletion... 87

7 7.1 7.2 7.3 7.4

SessionSync (Optional)... 89 About SessionSync... 89 Enable and disable SessionSync... 89 SessionSync Status icon... 90 Use Automatic SessionSync... 91

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50 51 51 52 52 53

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7.5 7.6 7.7 7.8

Use Manual SessionSync for supported devices... SessionSync error message descriptions... View SessionSync Status screen... Update SessionSync status...

92 92 93 93

8 8.1 8.2 8.3 8.4 8.5

Service the programmer... 95 Clean the system components... 95 Sterilize the programming head, ECG cable, and lead wires... 95 Programmer specifications... 97 Special notice... 100 Medtronic limited warranty... 100

A End-user license agreement... 101 A.1 End-user license agreement (EULA) terms... 101 Index... 106

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1 Introduction to the programmer 1.1 CE mark of conformity CE Mark

Models Applies to all Medtronic hardware and software (including 29901 and desktop software SW028). Applies to all Vitatron software (including desktop software VSH02).

Applies to Bluetooth only.

1.2 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

System meets the applicable Canadian and U.S. electrical safety standards. System meets the applicable Canadian and U.S. electrical safety standards. Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union Acts. 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.

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ACMA (Australian Communications and Media Authority) and the New Zealand Ministry of Economic Development Radio Spectrum Management standards for radio communications products symbol for Australia and New Zealand. MIC (Ministry of Internal Affairs and Communications) symbol for Japan

ICASA (Independent Communications Authority of South Africa) mark for South Africa. Use only with specified power supply.

Class II ME Equipment

Type BF applied part

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

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USB port

DC input ExpressCard

Battery

VGA monitor

Manufacturer

Date of manufacture

Authorized representative in the European community

Reorder number

Serial number

Lot number

Humidity limitation

Package contents

Programmer, software installed

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Power cord

Product documentation

Accessories

Programmer

Stylus / tether

Programming head

Power supply

Power cord

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

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Do not wrap cord behind head

Do not wrap cord around head

1.3 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.

1.4 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: ●

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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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1.5 Intended use The programmer is intended to be used to interrogate and program Medtronic and Vitatron implantable devices.

1.6 Contraindications There are no known contraindications to the use of the 29901 Programmer; the 29901 Programmer does not provide therapy.

1.7 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 Reference Manual

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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. 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. 14

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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. 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 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.

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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.

1.8 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 doors when opening or closing the storage doors. A painful pinch may result. 16

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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. 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.

1.8.1 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. ● ●

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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.

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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.

1.9 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.

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1.10 Regulatory compliance 1.10.1 US Federal Communications Commission (FCC) See label on bottom of programmer for specific ID number for your programmer.

1.10.1.1 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.

1.10.2 Industry Canada See label on bottom of programmer for specific ID number for your programmer. 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.

1.11 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.

1.11.1 Programming functions: ●

Permanent and temporary adjustment of parameter values.

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Selection of nominal parameter values established by Medtronic, Vitatron or by the user.

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Emergency button for VVI pacing.

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1.11.2 Telemetry functions: ●

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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.

1.11.3 ECG functions: ●

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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.

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Continuous multi-channel storage.

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Stimulation threshold test functions.

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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.

1.11.4 Software update function: ●

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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.

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1.12 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.

1.12.1 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.

1.12.2 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.

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