Medtronic 24967 User Manual
24967
Patient Connector
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, Medtronic
Contents
1 Introduction to the 24967 Patient Connector ............................................................... 4
1.1 Explanation of packaging and product symbols .......................................................... 4
1.2 Description ......................................................................................... 6
1.3 Intended use ....................................................................................... 6
1.4 Contraindications ................................................................................... 7
1.5 Warnings .......................................................................................... 7
1.6 Precautions ........................................................................................ 7
1.7 Regulatory compliance .............................................................................. 8
1.8 Patient Connector functions .......................................................................... 8
1.9 IT network, mobile device, and data information ......................................................... 8
2 Setup and configuration ................................................................................. 10
2.1 Contents of package ................................................................................ 10
2.2 System components ................................................................................ 10
2.3 Compatible accessories ............................................................................. 11
2.4 Setup ............................................................................................ 12
2.5 Charging the patient connector battery ................................................................ 13
2.6 Pairing the patient connector with the app ............................................................. 14
2.7 Troubleshooting potential interference ................................................................. 15
3 Conducting a patient session ............................................................................ 15
3.1 Positioning the patient connector ..................................................................... 15
3.2 Communicating with an implantable device ............................................................ 15
3.3 Troubleshooting .................................................................................... 16
4 Maintaining the patient connector ....................................................................... 17
4.1 Cleaning and disinfecting the 24967 patient connector .................................................. 17
4.2 Replacing the patient connector nose, cable, and weight ................................................. 21
4.3 Software updates .................................................................................. 23
4.4 Specifications ..................................................................................... 23
5 Electromagnetic compatibility declaration ................................................................ 24
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1 Introduction to the 24967 Patient Connector
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
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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
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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 24967 Patient Connector telemetry head (referred to from now on as the patient connector), pairs with Medtronic apps on your
mobile device to interrogate and/or program implantable Medtronic devices.
The patient connector includes these features:
• Low frequency inductive telemetry to communicate with implantable Medtronic devices.
• Bluetooth® wireless technology to communicate with implantable Medtronic devices and the apps running on the mobile device.
• Integration with the Medtronic 24970A Base for charging (not included).
1.3 Intended use
The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic
devices. The patient connector uses Bluetooth technology to transmit that data to a Medtronic app for further processing.
The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment
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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.
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1.4 Contraindications
There are no known contraindications for the use of this device.
1.5 Warnings
These warnings apply in general to using the patient connector settings. For more information related to specific implantable device
models, see the reference guides for the implantable device and the software.
Battery exposure – Exposing the patient connector to cold temperatures may result in a loss of performance and shortened patient
connector service life.
Connection of external devices – Additional equipment connected to medical electrical equipment must comply with the respective
IEC or ISO standards. All configurations must comply with the requirements for medical electrical systems, see IEC 60601-1 and IEC
60601-1-1. 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 patient connector if it has sustained impact damage. Internal components may be damaged
or exposed. Use of damaged equipment may impact user or patient safety.
Magnetic Resonance (MR) Unsafe – The patient connector is MR Unsafe. Do not bring the patient connector into Zone 4 (magnet
room), as defined by the American College of Radiology.
Modification of equipment – Do not modify this equipment. Modifications may reduce system effectiveness and impact user or
patient safety. Modifying the patient connector without the approval of Medtronic could void the user’s authority to operate the
equipment.
Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of the
patient connector. Although the patient connector has been approved, there is no guarantee that it will not receive interference or that
any particular transmission from the patient connector will be free from interference.
Unauthorized use – The patient connector can be used with any compatible mobile device onto which the app is installed.
Inappropriate programming could result if untrained persons obtain the patient connector and a patient with a Medtronic implantable
heart device allows them to use it with the patient’s device.
Use of unapproved power supply – Use only the Medtronic-supplied power supply with the patient connector. Use of an
unapproved power supply may damage equipment or impact user or patient safety.
1.6 Precautions
Attaching the tether kit – Do not overtighten the screw when attaching the tether kit.
Autoclaving – Do not autoclave the patient connector.
Damaged equipment – Periodically, inspect the patient connector, connection port, and cord for damage. If the case of the patient
connector is cracked, or if the power supply connector is damaged, contact your Medtronic representative. Replace the power supply
if there is damage to it. Dispose of the damaged power supply according to local regulations or return the part to Medtronic.
Do not immerse – Take care to prevent liquid from entering the patient connector. Do not immerse the patient connector or any
accessories in any liquid or clean them with aromatic or chlorinated hydrocarbons.
Maintenance and service – Do not modify or do any maintenance or service on the patient connector while you are using it. Doing
any of these tasks on the patient connector while it is in use can lower its effectiveness. Contact Medtronic at the number on the back
cover of this manual if your patient connector is not working properly.
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 patient connector to prevent unauthorized use that could lead to harm to
patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range
communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.
Sterility – The patient connector is not sterile and cannot be sterilized. For applications in which a sterile environment must be
maintained, place the patient connector inside of the Medtronic Model 6177 sterile sleeve.
Use of wireless devices – The patient connector 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 patient connector provides 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.
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If the patient connector 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 patient connector and other devices.
• Increase the separation between the patient connector and other devices by at least 2 m (approximately 6 feet). Other devices
include, but are not limited to, cellular phones, computer screens, wireless network devices, and ‘walkie-talkies’.
• Turn off any interfering equipment.
1.6.1 Environmental precautions
To ensure safe and effective operation, use the patient connector with care to avoid damage to the patient connector from
environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to the patient
connector under normal use. However, the patient connector is susceptible to many environmental stresses including, but not limited
to, the following examples.
• The patient connector is designed to be used indoors in a clinical or hospital environment.
• Do not drop or mishandle the patient connector or damage may occur. Damage can impair the functionality of the patient
connector. Even if the patient connector works immediately after being dropped, operational damage may have occurred that may
not be observed immediately.
• Do not spill fluid on the patient connector. Fluid incursion can occur and cause damage to the patient connector.
• The patient connector 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 patient connector.
• Do not open the case of the patient connector. The patient connector is constructed to minimize risk from environmental factors.
Opening the case of the patient connector can make it susceptible to environmental factors and can expose the patient or user
to hazardous voltage or current.
• Do not expose the patient connector to rapid temperature changes. Rapid temperature changes may affect proper operation of
the patient connector. If the patient connector is exposed to rapid temperature changes, allow the temperature to stabilize before
using it.
• Do not store or operate the patient connector for prolonged periods of time in high humidity. Prolonged storage or operation of the
patient connector in high humidity can affect proper operation.
If the patient connector is damaged, contact Medtronic at the telephone number on the back cover of this manual.
Other environmental factors can impair the performance of the patient connector. Always use good health management practices to
prevent environmental damage to the patient connector.
1.7 Regulatory compliance
1.7.1 US Federal Communications Commission (FCC)
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.
1.8 Patient Connector functions
The patient connector communicates with an implantable device. The patient connector also communicates with the Medtronic app
running on a mobile device.
1.9 IT network, mobile device, and data information
1.9.1 Required IT network characteristics and configuration
The use of the patient connector requires your network to have Internet access for the following purposes:
• Download and install the Medtronic app from the app store.
• Download and install Medtronic app updates and software updates for the patient connector.
• Register, download, and install app configuration files from the Medtronic Application Services (MAS), if the Medtronic app allows
it.
• Send data to the CareLink Network, if the Medtronic app allows it.
Failure to provide IT network access results in the following effects:
• You cannot install or update the Medtronic app because the mobile device is unable to access the Internet.
• You cannot install periodic updates and security enhancements that maintain the security of the Medtronic app because the
mobile device is unable to access the Internet.
• You cannot send downloaded Medtronic implantable device data to the CareLink Network.
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To use the Medtronic app, you must also enable Bluetooth wireless technology on your mobile device. The patient connector
communicates with the Medtronic app installed on the mobile device through a Bluetooth connection.
Failure to provide Bluetooth wireless communication access prevents the patient connector from communicating with the Medtronic
app. If Bluetooth connectivity is disabled, the patient connector cannot interrogate, analyze or program Medtronic implantable
devices.
Follow your organization’s processes and policies to configure your network and your mobile device.
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/24967
1.9.3 Intended information flows
Data is sent for processing through the system components in the following sequential order:
• Implantable device
• 24967 patient connector
• Medtronic app running on the mobile device
System logs are sent for processing through the system components in the following sequential order:
• 24967 patient connector
• Medtronic app running on the mobile device
• Internet
• Medtronic Application Services (MAS)
During installation and updates, the app sends 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 this 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 patient connector uses Bluetooth wireless technology to communication with the Medtronic app installed on the mobile device.
Data transmission rates over Bluetooth connections are highly dependent on the environment in which the patient connector and
mobile device are used. Transmission rates may degrade based on electrical interference from other radio emitters, distance between
the patient connector 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 patient connector 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 Medtronic 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 system, Medtronic recommends you implement the following security measures:
• Use the Medtronic 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 certificates match before connecting to Medtronic Application Services for app updates.
If you suspect a cybersecurity event has occurred, stop using the app (if possible) and contact your IT Security or Biomedical
department for information on how to confirm and respond to the suspected incident.
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