Medtronic 24965 User Manual
24965
Patient Connector
DRAFT
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 24965 Patient Connector .............. 4
1.1 Explanation of packaging and product symbols ........... 4
1.2 Description ................................ 5
1.3 Intended use ............................... 6
1.4 Contraindications ............................ 6
1.5 Warnings ................................. 6
1.6 Precautions ................................ 7
1.7 Regulatory compliance ......................... 8
1.8 Patient Connector functions ...................... 8
1.9 Security .................................. 8
1.10 Compatible components ........................ 9
2 Setup and configuration ........................... 9
2.1 System components ........................... 9
2.2 Setup ....................................11
3 Conducting a patient session ....................... 14
3.1 Position the patient connector ..................... 14
3.2 Communicating with an implanted device .............. 14
4 Maintaining the patient connector .................... 14
4.1 Cleaning and disinfecting the 24965 Patient Connector ...... 14
4.2 Software updates ............................15
4.3 Specifications ...............................15
3
1 Introduction to the 24965 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.
Caution
Consult instructions for use
Ingress protection
Use only with specified power supply
Type BF 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
Re-order number
Serial number
Package contents
Product documentation
4
Accessories
China RoHS
Bluetooth connection
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 standards) symbol for Australia and
New Zealand
For US audiences only
ETL Listed Mark
Technical Conformity (Ministry of Internal Affairs and Communications) mark for Japan
Transit temperature
Storage temperature
Security key
Patient Connector
Telemetry
1.2 Description
The 24965 Patient Connector (patient connector), when paired with Medtronic apps
on your mobile device, is used to interrogate and program implanted Medtronic
devices. Interrogated information can be viewed or sent to the CareLink Network.
5
1.3 Intended use
The patient connector is a portable electronic device using low frequency inductive
telemetry to communicate with Medtronic implanted heart devices. The patient
connector uses Bluetooth technology to transmit implanted heart device data to a
Medtronic Mobile app for further processing.
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.
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.
Diagnostic ultrasound – Diagnostic ultrasound is an imaging technique that is
used to visualize muscles and internal organs, their size, structures, and motion as
well as any pathological lesions. It also is used for fetal monitoring and to detect and
measure blood flow. Diagnostic ultrasound, such as echocardiogram, poses no risk
of electromagnetic interference.
Diathermy treatment (including therapeutic ultrasound) – Diathermy is a
treatment that involves the therapeutic heating of body tissues. Diathermy
treatments include high frequency, short wave, microwave, and therapeutic
ultrasound. Except for therapeutic ultrasound, do not use diathermy treatments on
cardiac device patients. Diathermy treatments may result in serious injury or
damage to an implanted device and lead system. Therapeutic ultrasound (including
physiotherapy, high intensity therapeutic ultrasound, and high intensity focused
ultrasound), is the use of ultrasound at higher energies than diagnostic ultrasound
to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if
treatment is performed with a minimum separation distance of 15 cm (6 in) between
the applicator and the implanted device and lead system, as long as the ultrasonic
beam is pointing away from the device and lead system.
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 device
without the approval of Medtronic could void the user’s authority to operate the
equipment.
Radiation therapy – Exposing the device to therapeutic levels of ionizing radiation
(such as that produced by cobalt machines or linear accelerators used for cancer
treatment) may trigger inappropriate episode detection or corrupt the data stored in
memory. It is advisable to check device function after radiation therapy. Cumulative
radiation levels above 5 Gy may permanently damage the device.
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 REVEAL LINQ patient
allows them to use it with the patient’s device.
6
Loading...