Medtronic D00U001 Technical Manual

CareLink SmartSync™ 24970A

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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 SmartSync, Conexus, Medtronic

1 Introduction to 24970A ..................................................................................... 4

1.1 Explanation of packaging and product symbols ................................................................. 4

1.2 Description ................................................................................................ 5

1.3 Intended use .............................................................................................. 5

1.4 Contraindications .......................................................................................... 6

1.5 Warnings ................................................................................................. 6

1.6 Precautions ............................................................................................... 7

1.7 Regulatory compliance ..................................................................................... 9

1.8 IT network, tablet, and data information ........................................................................ 9

2 Setup and configuration ................................................................................... 11

2.1 Contents of package ....................................................................................... 11

2.2 Components ............................................................................................. 11

2.3 Compatible accessories .................................................................................... 15

2.4 Setup .................................................................................................... 16

2.5 Connecting the base to the device manager app ............................................................... 20

2.6 Connecting the ECG cable ................................................................................. 21

2.7 Charging the patient connector battery ....................................................................... 21

2.8 Troubleshooting potential interference ........................................................................ 22

3 Conducting an analyzer session ............................................................................ 23

3.1 Conducting an analyzer session ............................................................................. 23

3.2 Delivering emergency VVI pacing ............................................................................ 25

3.3 Troubleshooting ........................................................................................... 25

4 Maintaining the base ...................................................................................... 26

4.1 Cleaning the base ......................................................................................... 26

4.2 Specifications ............................................................................................ 28

4.3 Expected service life and disposal of the base ................................................................. 30

5 Technical information ...................................................................................... 30

5.1 Essential performance characteristics ........................................................................ 30

5.2 Electromagnetic compatibility declaration ..................................................................... 30

1 Introduction to 24970A

1.1 Explanation of packaging and product symbols

To see which symbols apply to this product, refer to the package label and product.

Consult instructions for use at medtronic.com/manuals.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts.

Ingress protection

Use only with specified power supply

Class II ME equipment

Type BF applied part

Type CF applied part

Humidity limitation

Non-ionizing electromagnetic radiation

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See recycling.medtronic.com for instructions on proper disposal of this product.

Direct current

Manufacturer

Date of manufacture

Authorized representative in the European Community

For US audiences only

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician

Reorder number

Serial number

Package contents

Product documentation

Accessories

Magnetic Resonance (MR) Unsafe

Bluetooth connection

Wireless communication enabled

Telemetry enabled

Caution: Strong magnet

Follow instructions for use (blue)

Low battery

Keep dry

ACMA (Australian Communications and Media Authority) and the New Zealand Ministry of Economic Development Radio Spectrum Management compliance mark for Australia and New Zealand

System meets the applicable Canadian and US IEC safety standards

Technical Conformity (Ministry of Internal Affairs and Communications) mark for Japan

Temperature limit

Transit temperature

Storage temperature

Security key

Base

24967 patient connector

249701 power supply for the 24970A base

249705 power cord for the 24970A base

249651 power supply for the 24967 patient connector

249672 tether kit

249702 USB cable

249671 weight kit

1.2 Description

The CareLink SmartSync Model 24970A base (referred to as the base) provides the analyzer and ECG hardware during device implant, invasive troubleshooting, and implanted device follow-up procedures.

The base includes the following features:

• Analyzer hardware and patient cable connections — Supports the electrical assessment of cardiac leads during implant.

• ECG cable connections — Collects live cardiac waveform data that you can view, measure, and record using the CareLink SmartSync Device Manager Application (referred to as the device manager app).

• USB cable connection — Charges the Model 24967 patient connector (referred to as the patient connector) and transmits data between the patient connector and the device manager app.

• Charge cradle — Charges the patient connector.

• Bluetooth® wireless technology — Method of communication with the device manager app1.

The base is a component of the CareLink SmartSync device manager. The device manager also includes the following components:

• Patient connector — Interrogates and programs implantable devices.

• Device manager app — Primary interface of the device manager. From the device manager app, you can access the implantable device app and CareLink SmartSync PSA (Pacing System Analyzer) Application (referred to as the analyzer).

1.3 Intended use

The device manager is intended to be used to interrogate and program Medtronic implantable devices and conduct a cardiac lead analysis session during Medtronic heart device implant or invasive troubleshooting.

The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any such use of those marks by Medtronic is under license.

The base provides the analyzer and ECG hardware for use during device implant, invasive troubleshooting, and implanted device follow-up procedures. The base also provides a charge cradle and USB port to charge the patient connector. Additionally, the USB port is used to transmit data between the patient connector and the device manager app.

The base is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital environment.

1.4 Contraindications

Do not use the base as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient’s age and medical condition may dictate the pacing modes and lead analyses appropriate for the patient.

1.5 Warnings

These warnings apply in general when using the device manager. For more information related to specific implantable device models, see the reference guides for the implantable device and the software.

Battery replacement – The AA LR6 alkaline or FR6 lithium batteries that power the integrated analyzer hardware in the base must be replaced every 2 years or when they are depleted. Replace the batteries every 2 years or when the device manager app indicates that the battery charge is low. Use of a failed battery may reduce operating time and may cause user or patient injury.

Do not replace the battery while an analyzer session is in progress or when the base is connected to a patient. The battery connects to circuitry that connects directly to the patient and could provide a low-resistance path to the myocardium for electrostatic discharge (ESD) or leakage currents.

Changing polarity settings – Confirm the polarity capabilities of the cardiac lead system before changing polarity settings. Changing polarity settings could result in loss of pacing if the cardiac lead system is not set up to facilitate pacing in the polarity selected.

Cable connections – Connect all surgical cables, patient cables, and adaptors to the base before connecting the leads to the surgical or patient cable. Ensure proper atrial or ventricular lead connections are made to the surgical or patient cables. For more information on connecting surgical or patient cables to leads, refer to the instructions for use for the selected surgical or patient cable.

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 Medtronic Technical Services. See the back cover for contact information.

Damage due to impact – Do not use the base if it has sustained impact damage. Internal components may be damaged or exposed. Use of damaged equipment may impact user or patient safety.

DDD pacing mode – Do not operate the analyzer in the DDD pacing mode when only the ventricular pacing lead is connected. Interference detected at the unconnected atrial input of the analyzer can result in false sensing and can drive the ventricular pacing rate to the Upper Rate setting.

Defibrillation or cardioversion – Whenever possible, for the safety of the patient, disconnect the base from the cardiac lead system before defibrillating or cardioverting.

Defibrillatory discharges may damage the analyzer hardware in the base when the base is connected to an indwelling cardiac lead system.

• The analyzer recovers normal operation within 2 seconds in the ventricle and within 6 seconds in the atrium for the defibrillation test pulse defined in IEC 60601-2-31.

• Test the analyzer after it is exposed to such charges.

Diagnostic ECG – Do not use the ECG display for diagnosis. Use a separate ECG device if diagnostic ECG capabilities are required. Electric shock risk – Do not simultaneously touch the patient and any metal parts of the base (such as the USB port, power

connector, or patient connector charging contacts) as voltage may be present. Application of voltage to the patient may impact user or patient safety.

Electrostatic discharge (ESD) – Discharge any static electricity from your body before touching the patient, the cable, the leads, or the base. The pacing leads provide a low-impedance pathway to the heart.

Electrosurgical units (cautery) – Do not use electrosurgical units within 15 cm (6 in) of the cardiac lead system. Electrosurgical units can cause tachyarrhythmias by inducing current on the leads.

Equipment compatibility – The device manager should be used only for the assessment of implanted cardiac lead systems for compatible implantable devices from Medtronic. Use of the device manager with implantable devices from other manufacturers may result in incompatible measurements. Medtronic does not accept responsibility for measurements taken using the device manager with implantable devices from other manufacturers.

Flammable anesthetic mixture – The device manager is not suited for use in the presence of a flammable anesthetic mixture.

Handling inserted leads – Do not touch the exposed metal of the connector ends of the leads or the exposed metal of the cable clips when handling inserted leads. Do not allow the exposed metal of the connector end of the leads or the exposed metal of the cable clips to unintentionally contact electrically conductive or wet surfaces.

High output and maximum sensitivity – Avoid using high output (high amplitude and wide pulse width) and maximum sensitivity simultaneously. This combination may result in oversensing intrinsic events, far-field sensing of intrinsic events, or sensing of paced events. The combination of high output and maximum sensitivity may include the following effects:

• Use of high atrial sensitivity (low numerical settings) may allow ventricular potentials to inappropriately inhibit or trigger the atrial output in the presence of large ventricular depolarization potentials or high output.

• High output and maximum sensitivity may result in opposite-chamber sensing of the pace output. The analyzer hardware in the base includes a safety pacing feature to prevent inappropriate inhibition of ventricular pacing due to far-field sensing.

• Use of high sensitivity in the ventricle may result in inappropriate inhibition of the ventricular output due to T-wave or myopotential sensing.

Importance of instructions for use – Before using the device manager, Medtronic recommends that you take the following actions:

• Read the device manager instructions for use.

• Read the instructions for use for the leads and implantable device.

• Carefully assess the patient condition and the implantable device system to determine the appropriate settings for tests and device programming.

Improper use of the device manager could result in erroneous programming, inadvertent pacing, improper operation of telemetry, and incorrect operation of measurement functions.

Line-powered equipment – During lead implantation and testing, use only battery-powered equipment (or line-powered equipment specifically designed for this purpose) to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment. An implanted lead forms a direct, low-resistance current pathway to the myocardium.

Magnetic resonance (MR) unsafe – The device manager is MR Unsafe. Do not bring any components of the device manager into Zone 4 (magnet room), as defined by the American College of Radiology.

Modification of equipment – Do not modify any hardware or software component of the device manager. Modifications may reduce system effectiveness and impact user or patient safety. Modifying any component without the approval of Medtronic could void the user’s authority to operate the equipment.

Prolonged power loss – Connect the patient to an external temporary pacemaker in the event of a prolonged power loss of more than 5 min.

Rapid atrial stimulation – Have defibrillation equipment readily available during rapid atrial stimulation. Use of high rates in the atrium can result in high-rate conduction to the ventricle. Accidental high-rate stimulation of the ventricles may result in ventricular tachycardia or fibrillation.

Radiofrequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of components of the device manager. There is no guarantee that the device manager will not receive interference or that any particular transmission from this system will be free from interference.

Temporary pacing – Do not leave the patient unattended when the analyzer hardware in the base provides external pacing. The analyzer is a diagnostic device. If prolonged external pacing is needed, move the patient to an external pulse generator.

1.6 Precautions

This device has been tested for compliance with FCC regulations. Changes or modifications of any kind not expressly approved by Medtronic could void the user’s authority to operate this device.

Autoclaving – Do not autoclave the device. Base and power cord positioning – Position the base and its power cord so that the cord can be easily accessed and disconnected.

Route all cords away from trafficked areas or secure them to prevent accidental tripping or kicking. The power cord is heavy and may pull the base from the table and cause damage to the base. If needed, secure the power cord to the table with tape, gauze, or a clamp. If it is necessary to disconnect the base from the AC power mains, the power cord is the power disconnect at the mains outlet.

Damaged equipment – Periodically, inspect the base, its case and connection ports, and all cords and cables for damage. If the base is cracked or if any of its connectors are damaged, contact your Medtronic representative. Replace the power supply and cord if they are damaged. Replace any accessory cables if the insulation or plug is damaged. Dispose of the damaged part according to local regulations or return the part to Medtronic.

Do not immerse – Prevent liquid from entering the base. Do not immerse the base or any accessories in any liquid, and do not clean them with glycol ethers or aromatic or chlorinated hydrocarbons.

Electrical and patient safety – The device manager is compliant with the requirements of IEC 60601-1 for electrical and patient safety.

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.

Electromagnetic interference (EMI) – The base has been tested for compliance with industrial and medical EMI regulations. Any use outside the patient environment may result in malfunction.

Avoid excessive levels of EMI when working with analyzer functions, if possible. At high sensitivity settings and in the presence of excessive levels of interference, the analyzer may inhibit completely or revert to asynchronous pacing operation, pacing at the lower rate.

The following list includes sources of excessively strong EMI that may temporarily affect the operation of the analyzer hardware in the base:

• Electrosurgical equipment

• Diathermy equipment

• Radio frequency identification (RFID) equipment

• Some medical telemetry equipment (when operated within 1 m [about 3 feet] of the base)

• Communication transmitters such as cellular phones and two-way radios

Finger injury – To avoid a painful pinch, do not place fingers in the hinge area when lifting or closing the base lid. Maintenance and service – Do not modify or do any maintenance or service on the base while you are using it. Modifying or

maintaining the base while it is in use can lower its effectiveness. If your base is not working properly, contact your Medtronic representative.

Magnetic interference – The base includes a magnet under the charge cradle to secure the patient connector and ensure charging. The symbol on the cradle identifies the location of this magnet. Avoid placing devices or material that may be damaged by the magnetic field (such as magnetic media, watches, or other electronic devices) on top of the base.

Some tablets may be sensitive to magnetic interference. Keep strong magnetic sources (such as magnetic programming heads, patient magnets like the Model 9466 Tachy Patient Magnet, or other strong magnetic field generators) away from direct contact with the tablet when working with the device manager.

Note that the Model 24967 patient connector does not include a magnet and is not a source of magnetic interference. Measurement function – The analyzer is designed to detect and measure pulse rate, AV interval and pulse width, and implantable

device pace artifacts. The base takes these digital measurements with the assistance of optional skin electrodes that collect ECG signals. Medtronic makes no claims or warranties as to the effectiveness of this measurement function as a diagnostic tool to the physician.

Pediatric use – The device manager and its components have not been tested specifically for pediatric use. 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. Security – Maintain adequate physical security of the base to prevent unauthorized use that could lead to harm to patients. Bluetooth

communication in the base is encrypted for security. Single complex monitor – If the single complex monitor is selected on the analyzer, connect the patient to a separate ECG monitor

in order to view a continuous ECG. The single complex monitor replaces the continuous waveform monitor on the display, eliminating your view of complete heart activity.

Use of wireless devices – The device manager incorporates radiofrequency (RF) communications components that 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.

Electromagnetic compatibility (EMC) compliance testing shows that the components of the device manager provide reasonable protection against harmful interference and provide EMC immunity in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation.

If any component does cause harmful interference to other devices or is negatively impacted by other devices or by the environment, correct the interference by taking one or more of the following measures:

• Reorient or relocate the component and other devices.

• Ensure that the base is placed at the level of or on top of tables (and not below table level). Placing the base below table level can negatively impact communication and connectivity.

• Increase the separation between the component and other devices by at least 2 m (approximately 6 feet).

• Turn off any interfering equipment.

1.6.1 Environmental precautions

Although the base was designed to withstand normal use, take the following precautions to avoid damage from environmental stresses:

• Do not drop the base or handle it in a way that might physically damage it. The base may appear to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred.

• Do not spill fluid on the base. Fluid incursion can damage the base.

• In an environment likely to cause electrostatic discharge (ESD), such as a carpeted floor, discharge any charge collected on your body before touching the base. Electrostatic discharge (ESD) may affect the base.

• Do not open the case of the base. Opening the case can make it susceptible to environmental factors and can expose the patient or user to a hazardous voltage or current.

• Do not expose the base to rapid temperature changes. Rapid temperature changes may affect proper operation. If the base is exposed to rapid temperature changes, allow the temperature to stabilize before using the base.

• Do not store or operate the base for prolonged periods of time in high humidity. Prolonged storage or operation of the base in high humidity may affect proper operation.

• Place the base on a table or other hard surface and position it to avoid contact with the patient; it is not intended to be used while supported by or in contact with the patient.

If the base is damaged, contact Medtronic at the telephone number on the back cover of this manual. Other environmental factors can impair the performance of the base. Always use good health management practices to prevent

environmental damage to the base.

1.7 Regulatory compliance

1.7.1 US Federal Communications Commission (FCC)

This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) 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 stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication 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.

1.8 IT network, tablet, and data information

1.8.1 Required IT network characteristics and configuration

To use the device manager, your tablet must have both Bluetooth wireless technology and access to the Internet.

Bluetooth wireless technology

You must enable Bluetooth wireless technology on your tablet. The hardware components of the device manager communicate with the device manager app, installed on the tablet, through a Bluetooth connection.

Failure to provide Bluetooth communication access prevents the device manager components from communicating with each other and with implantable devices, which results in the following limitations:

• The device manager app is unable to establish a Bluetooth connection with the base, which prevents access to the analyzer and prevents the ability to view ECG waveforms.

• The device manager app is unable to establish a Bluetooth connection with the patient connector. The patient connector is used to interrogate and program the implantable cardiac device.

Internet

To configure your network, follow the processes and policies of your organization. To set up or update the device manager, your network must have Internet access. When your network is configured to access the

Internet, you can complete the following actions:

• Download and install the device manager app.

• Register the device manager app.

• Download and install software or updates necessary for the device manager to function.

Failure to provide information technology (IT) network access prevents the tablet from accessing the Internet, which results in the following limitations:

• Inability to install or update the device manager app and software components

• Inability to download firmware updates for the base and patient connector

• Inability to receive periodic updates and security enhancements that maintain the security of the device manager app

• Inability to process device manager component system logs

• Inability to authenticate the first connection between the device manager app and the base and patient connector

Note: Internet access is not required to export and print reports. However, failure to provide IT network access (for example, Wi-Fi or cellular) results in the inability to export and print reports using a wireless connection.

1.8.2 Supported tablets and technical specifications

To use the device manager, your tablet must meet certain requirements. Note: The device manager app may not be compatible with the most current version of the tablet operating system. For more information on the requirements, refer to the CareLink SmartSync Tablet Compatibility Technical Manual. To download or

order the CareLink SmartSync Tablet Compatibility Technical Manual, go to medtronic.com/manuals.

1.8.3 Intended information flows

The implantable cardiac device lead data processes through the device manager components in the following order:

• Implantable cardiac device leads

• Base (via cables connected to the leads and to the base)

• Device manager app

The system logs process through the device manager components in the following order:

• Base

• Device manager app

• Internet

• Medtronic servers

During installation and updates, the device manager app sends your clinic registration and device manager credentials to Medtronic via the Internet for authentication. In response, Medtronic returns configuration files to the device manager app via the Internet to install or update the device manager app and component software as needed.

All information in transit is protected for security.

1.8.4 Precautions when connecting to your IT network

Connecting the device manager to an IT network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your IT network, such as adding, disconnecting, updating or upgrading equipment, or changing network configurations, could introduce additional risks. Analyze, evaluate, report, and control any risks identified.

1.8.5 Data transmissions

The device manager uses Bluetooth wireless technology to allow communication between the base and device manager app. Data transmission rates over Bluetooth connections are highly dependent on the environment in which the base and tablet are used. Transmission rates may degrade based on electrical interference from other radio emitters, distance between the base and the tablet, and wireless or cellular settings on the tablet.

All data transmitted between the base and the device manager app is encrypted for data privacy. Data integrity is maintained through standard communication protocols for error detection.

1.8.6 Security

Data in the device manager app is protected by encryption. The device manager app is unable to provide data protection for data exported to another destination. Handle and store the data that you export from the device manager app in accordance with the security policy of your clinic.

To protect patient health information, the tablet must be secured with a passcode. The device manager is unable to function if a passcode is not defined. For more information on securing the tablet with a passcode, refer to the user instructions for your tablet.

To protect the device manager, Medtronic recommends that you implement the following security measures:

• Use the device manager app and device manager components only on a managed, trusted network. Verify that your Wi-Fi networks comply, at minimum, with wireless standard 802.11b, 802.11g, or 802.11n, and use WPA2 or stronger encryption.

• Secure your network with industry best practices, which can include antivirus software, firewalls, and wireless security policies, according to the policies of your IT department.

• When installing or updating the device manager app, if your tablet displays a message indicating that a security certificate is invalid, the installation or update process is unable to continue. For assistance, contact your local Medtronic representative.

The device manager app closes automatically when the device manager app detects a failure to maintain security. If you suspect that a cybersecurity event has occurred, stop using the device manager app (if possible). Contact your IT security or

biomedical department for information on how to confirm and respond to the suspected incident.

2 Setup and configuration

2.1 Contents of package

To set up the base, use the required and optional items from the base package. The package contains the following items:

• 24970A base

• ME20A0540F03 power supply (Medtronic reorder number: 249701), 1.8 m (approximately 6 ft)

• AA LR6 alkaline batteries, quantity of 2

• 249702 USB cable, approximately 3 m (10 ft)

• #1 Phillips-head screwdriver and screws

• Literature

2.2 Components

Figure 1. System components

1 Base 2 Patient connector 3 Batteries 4 Power cord

Base – Encloses the analyzer hardware that connects to a patient’s implantable cardiac device lead system. The analyzer assesses the electrical performance of the implantable cardiac device lead system. The base provides the communication link between the analyzer hardware and the device manager app for lead analysis. The base contains a radiofrequency (RF) transmitter and receiver.

Tablet (not included) – When the device manager app is open and connected to the base, provides the interface to assess the electrical performance and placement of implantable cardiac device lead systems.

Patient connector (not included) – Provides the communication link between the device manager app and the implantable device. The patient connector has a blue counter weight. The weight can be placed over the shoulder of the patient to hold the patient connector in place for hands-free use.

For more information about the patient connector, refer to its technical manual.

5 Power supply 6 USB cable 7 Tether kit 8 Screwdriver and screws

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