Medtronic 24970A User Manual

CareLink SmartSync™ 24970A

Base

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, Medtronic CareLink

1 Introduction to the 24970A Base .......................................................................... 4

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

1.2 Description ......................................................................................... 6

1.3 Intended use ....................................................................................... 7

1.4 Contraindications ................................................................................... 7

1.5 Warnings .......................................................................................... 7

1.6 Precautions ........................................................................................ 8

1.7 24970A base functions ............................................................................. 10

1.8 Regulatory compliance ............................................................................. 10

1.9 IT network, mobile device, and data information ........................................................ 10

2 Setup and configuration ................................................................................. 12

2.1 Contents of package ................................................................................ 12

2.2 System components ................................................................................ 12

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

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

2.5 Connecting the base to the app ...................................................................... 19

2.6 Charging the patient connector battery ................................................................ 22

2.7 Troubleshooting potential interference ................................................................. 23

3 Conducting an Analyzer session ......................................................................... 24

3.1 Conducting an Analyzer session ..................................................................... 24

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

3.3 Troubleshooting .................................................................................... 26

4 Maintaining the 24970A base ............................................................................ 27

4.1 Cleaning the 24970A base .......................................................................... 27

4.2 Specifications ..................................................................................... 30

5 Electromagnetic compatibility declaration ................................................................ 31

1 Introduction to the 24970A Base

1.1 Explanation of packaging and product symbols

Refer to the package label and product to see which symbols apply to this product.

Consult instructions for use at www.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 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 http://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

Re-order 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 U.S. IEC safety standards

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

Operating temperature

Transit temperature

Storage temperature

Security key

24970A Device manager

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 Device Manager system (referred to from now on as the device manager system) is comprised of the Model 24970A Base, Model 24967 Patient Connector (also referred to as a telemetry head), and CareLink SmartSync Device Manager app installed and running on your mobile device. The CareLink SmartSync Device Manager Base (referred to from now on as the base) pairs with the Medtronic CareLink SmartSync Device Manager app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device.

The base includes these features:

• Analyzer hardware and patient cable connections to support electrical assessment of cardiac leads during implant.

• ECG cable connections to collect live cardiac waveform data that can be viewed, measured, and recorded using the app running on your mobile device.

• Bluetooth® wireless technology to communicate with the app running on your mobile device.

• A cradle to charge the Medtronic 24967 Patient Connector (referred to from now on as the patient connector).

• Optional USB connectivity to charge the patient connector.

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.

1.3 Intended use

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms.

The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

1.4 Contraindications

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

1.5 Warnings

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

Battery replacement – The 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 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 the base is connected to a patient. The battery connects to circuitry which 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 the technical service department.

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 hardware in the base in the DDD pacing mode when only the ventricular pacing lead is connected. Interference detected at the unconnected atrial input of the Analyzer hardware can result in false sensing and can drive the ventricular pacing rate to the Upper Rate setting.

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

The Analyzer hardware in the base may be damaged by defibrillatory discharges when it is connected to an indwelling cardiac lead system.

• The Analyzer hardware recovers normal operation within two seconds in the ventricle and within six seconds in the atrium for the defibrillation test pulse defined in IEC 60601-2-31.

• The Analyzer hardware should be tested after being 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 system should be used only for the assessment of implantable cardiac lead systems for Medtronic-compatible implantable devices. Use of the device manager system with implantable devices from other manufacturers may result in incompatible measurements. Medtronic does not accept responsiblity for measurements taken using the device manager system with implantable devices from other manufacturers.

Flammable anesthetic mixture – The device manager system 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 over-sensing 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 conducting an Analyzer session, Medtronic recommends that you take the following actions:

• Read the CareLink SmartSync Device Manager product instructions for use for information about using the device manager system to assess the electrical performance of Medtronic implantable device cardiac lead systems.

• Thoroughly read the instructions for use for the leads used with the implantable device.

• Carefully assess the patient’s condition and pacing system used to determine the appropriate parameter values to use during lead analysis.

The instructions contained in this guide are liminted to the mechanics of setting up the device manager system and selecting the correct options for the desired lead assessment tests. Improper use of the device manager system could result in erroneous or inadvertent pacing and improper operation of telemetry and 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 system is MR Unsafe. Do not bring any components of the device manager system 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 system. 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 five minutes.

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.

Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of components of the device manager system. Although the device manager 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.

Supply mains with protective earth – To avoid the risk of electric shock, connect the power supply only to a hospital-grade supply mains receptacle with a protective earth. The third conductor in the power cord plug is a functional earth connection.

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

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, causing damage to it. 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 if there is damage

to it, the power cord, or the wall plugs. 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 – Take care to prevent liquid from entering the base. Do not immerse the base or any accessories in any liquid or clean them with glycol ethers or aromatic or chlorinated hydrocarbons.

Electrical and patient safety – The CareLink SmartSync Device Manager system is compliant with the requirements of UL/CUL/EN 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

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

• Communication transmitters such as cellular phones and “walkie talkies”

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. Doing any of these

tasks on the base while it is in use can lower its effectiveness. Contact Medtronic if your base is not working properly. 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 mobile devices 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 mobile device when working with the device manager system.

The 24967 Patient Connector telemetry head does not include a magnet and is not a source of magnetic interference. Measurement function – The device manager system is designed to detect and measure pulse rate, AV interval and pulse width,

and implantable device artifacts. The base takes these digital measurements with the assistance of optional skin electrodes. Medtronic makes no claims or warranties as to the effectiveness of the device manager system as a diagnostic tool to the physician.

Pediatric use – The device manager system 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. Single complex monitor – If the single complex monitor is selected in the app, 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 app display, thereby eliminating indication of complete heart activity.

Use of wireless devices – The device manager system 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.

Electromagnetic Compliance (EMC) testing shows that the components of the device manager system provide reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. 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, correct the interference by one or more of the following measures:

• Reorient or relocate the component and other devices.

• Ensure 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

To ensure safe and effective operation, use the base with care to avoid damage from environmental factors that may impair its function. The base has been carefully designed and tested to ensure reliability during normal use. However, the base is susceptible to many environmental stresses including, but not limited to, the following examples.

• The base is designed to be used indoors in a clinical or hospital environment.

• Do not drop the base or handle it in a way that might physically damage it. Damage can impair the functionality of the base. 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 occur and cause damage to the base.

• The base 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 base.

• Do not open the case. The base is constructed to minimize risk from environmental factors. Opening the case can make it susceptible to environmental factors and can expose the patient or user to 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 it.

• 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.

• Ensure the base is placed at the level of or on top of tables. Placing the base below table level can negatively impact communication and connectivity.

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 24970A base functions

The base and the Analyzer hardware within the base supports the following functions:

• Communication with the Medtronic app running on your mobile device via a Bluetooth wireless connection.

• Collection of live cardiac waveform data via ECG cable connections that can be viewed, measured, and recorded using the app running on your mobile device.

• Electrical assessment of cardiac leads during implant via patient cable connections to the Analyzer hardware in the base.

• Charging of the 24967 patient connector via the base charging cradle or USB cable.

1.8 Regulatory compliance

1.8.1 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.

1.9 IT network, mobile device, and data information

1.9.1 Required IT network characteristics and configuration

The use of the device manager system requires your network to have Internet access for the following purposes:

• Download and install the CareLink SmartSync Device Manager app from the app store.

• Register, download, and install app configuration files, app updates, and software updates for device manager components from Medtronic Application Services (MAS).

To use the device manager system, you must also enable Bluetooth wireless technology on your mobile device. The hardware components of the device manager system communicate with the app installed on the mobile device through a Bluetooth connection.

Failure to provide IT network access results in the following effects:

• You cannot install or update the CareLink SmartSync Device Manager app, Analyzer tools, or software for device manager system components because the mobile device is unable to access the Internet.

• You cannot receive periodic updates and security enhancements that maintain the security of the application because the device is unable to access the Internet.

Failure to provide Bluetooth wireless communication access prevents the device manager system components from communicating with each other and patient devices. If Bluetooth connectivity is disabled, the device manager system cannot successfully assess the electrical performance of implantable cardiac device leads because the mobile device is unable to establish Bluetooth connections with the base. You cannot conduct lead tests if Bluetooth connectivity is disabled on the mobile device.

Follow your organization’s processes and policies to configure your network.

1.9.2 Supported mobile devices and technical specifications

For a list of supported mobile devices and their specifications, including network connectivity specifications, go to the following website:

www.medtronic.com/SmartSync For licensing disclosures for the open source components used in the app, go to the following website: www.medtronic.com/SmartSync

1.9.3 Intended information flows

Implantable cardiac device lead data are sent for processing through the device manager system components in the following sequential order:

• Implantable cardiac device leads

• 24970A base (via cables connected to the leads and to the base)

• CareLink SmartSync Device Manager app installed on the mobile device

System logs are sent for processing through the device manager system components in the following sequential order:

• 24970A base

• CareLink SmartSync Device Manager app installed on the mobile device

• Internet

• Medtronic Application Services (MAS)

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

All information in transit is protected for security.

1.9.4 Precautions when connecting to your IT network

Connecting the device manager system 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, and upgrading equipment or changing network configurations could also introduce additional risks. Analyze, evaluate, report, and control any risks identified.

1.9.5 Data transmissions

The CareLink SmartSync Device Manager system uses Bluetooth wireless technology to allow communication between the 24970A base and app installed on the mobile device. Data transmission rates over Bluetooth connections are highly dependent on the environment in which the base and mobile device are used. Transmission rates may degrade based on electrical interference from other radio emitters, distance between the base and the mobile device, and wireless or cellular settings on the mobile device. Maximum data throughput in an ideal environment is 2.1 Mbit/s with a latency of 5 to 10 ms.

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

1.9.6 Security

Data in the CareLink SmartSync Device Manager app is protected by application level encryption. The app does not provide data protection for data exported to another destination. Data exported from the app should be handled in accordance with your clinic’s security policy for data handling and storage.

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

• Use the CareLink SmartSync Device Manager app and system components only on a managed, trusted network.

• Secure your network with anti-virus software or a firewall, in line with your IT department’s policies.

• To help protect patient health information, implement security measures such as a passcode and PIN to protect the mobile device.

• Ensure security certficates match before connecting to Medtronic Application Services for app updates.

+ 25 hidden pages