Medtronic 24965 24965 User Manual MAPS ID 502120 002

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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
Introduction to the 24965 Patient Connector . . .
1.1
Explanation of packaging and product symbols
1.2
Description . . . . . . . . . . . . . . . . . . . . .
1.3
Intended use . . . . . . . . . . . . . . . . . . . .
1.4
Contraindications . . . . . . . . . . . . . . . . .
1.5
Warnings . . . . . . . . . . . . . . . . . . . . . .
1.6
Precautions . . . . . . . . . . . . . . . . . . . . .
1.7
Regulatory compliance . . . . . . . . . . . . . .
1.8
Patient Connector functions . . . . . . . . . . .
1.9
Security . . . . . . . . . . . . . . . . . . . . . . .
1.10 Compatible components . . . . . . . . . . . . .
Setup and configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1
System components . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Conducting a patient session . . . . . . . . . . . . . . . . . . . . . . . 14
3.1
Position the patient connector . . . . . . . . . . . . . . . . . . . . . 14
3.2
Communicating with an implanted device . . . . . . . . . . . . . . 14
Maintaining the patient connector . . . . . . . . . . . . . . .
4.1
Cleaning and disinfecting the 24965 Patient Connector
4.2
Software updates . . . . . . . . . . . . . . . . . . . . . .
4.3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . .
. 14
. . 14
. . 15
. . 15
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
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.
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.
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 – If the case of the patient connector is cracked or if any of
the connectors are damaged, contact your Medtronic representative. If there is
damage to the power supply cord, replace the part and dispose of it 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.
Electrocautery/external defibrillation – Do not position the patient connector
over an implanted device during electrocautery or external defibrillation
procedures.
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.
Radio-frequency (RF) interference – Portable and mobile RF communications
equipment can interfere with the operation of the patient connector. 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. To
avoid interference, do not use the patient connector and mobile device within 2 m (6
feet) of a television, computer monitor or screen, or other wireless communications
equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, or “walkie-talkies”. Using your patient connector
near these devices could interfere with communication between your implanted
heart device and the patient connector.
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. Inductive telemetry (A/B) uses
short-range communication to protect patient information. If the patient connector
should fail, there is no risk of patient harm.
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.
1.6.1 Environmental precautions
To ensure safe and effective operation, use the device 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 devices under
normal use. However, electronic devices are susceptible to many environmental
stresses including, but not limited to, the following examples.
• 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 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 device.
• Do not open the device. The patient connector 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 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.
1.7 Regulatory compliance
1.7.1 US Federal Communications Commission (FCC)
FCC ID: LF524965 (for patient connector). Contains FCC ID: T7V1316.
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 implanted device. The patient
connector also communicates with the Medtronic app running on a mobile device.
1.9 Security
1.9.1 What hospitals and clinics can do to promote the security of patient
connectors
Maintain good physical controls over the patient connector. Having a secure
physical environment prevents access to the internals of the patient connector.
Only connect the patient connector to managed, secure networks.
Update the software on the patient connector when Medtronic updates are
available.
To increase security, store the patient connector and paired mobile device together
in a secure location when not in use.
1.9.2 What to do if you suspect the patient connector has been
compromised
Discontinue use of the patient connector if it does not behave as expected. Contact
your Medtronic representative for further assistance.
1.10 Compatible components
The following compatible components are available for the patient connector:
• Power supply
• Tether kit
• Medtronic Model 6177 sterile sleeve
Contact your local Medtronic representative to order them.
Warning: Use the Medtronic-supplied components only. Use of unapproved
components may reduce device effectiveness or impact user or patient safety.
2 Setup and configuration
2.1 System components
Figure 1. Patient Connector components
1 Power supply
2 Patient Connector
Patient Connector – Provides the communication link between the app and the
patient’s implanted device. The patient connector contains a radio-frequency (RF)
transmitter and receiver. It must be held over the implanted device during a
communication session.
Mobile device (not supplied) – When running the Medtronic app and paired with
the patient connector, provides the user interface to communicate and program the
implanted device, depending on the app installed.
Power supply – Connects to an AC power outlet to charge the patient connector
battery.
Tether kit – Semi-permanently connects the patient connector to the power cord.
Contains an Allen wrench, screw, and cable retainer.
Warning: 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.
10
2.1.1 Indicator lights
Figure 2.
1 Telemetry Status
2 Bluetooth Connection Status
3 Battery Status
Table 1. Table with title and rules above and below header
Icon
Indicator
Color
Telemetry Status Green
Bluetooth Connec- Blue
tion Status
Battery Status
Amber
2.2 Setup
This section describes how to:
•
•
•
•
•
•
Charge the patient connector battery
Download the app
Pair the patient connector with the app
Turn on the patient connector
Attach the tether kit (optional)
Troubleshoot potential interference
11
Description
When lit, indicates
that the patient
connector is communicating with the
implanted device.
When flashing,
indicates the
patient connector
is paired to the app
and ready to use.
When steadily lit,
indicates the
patient connector
is in use.
When lit, indicates
the patient connector battery is low
and should be
charged.
2.2.1 Charging the patient connector battery
1. Open the power supply connector cover located on the bottom edge of the
patient connector.
2. Connect power supply to the patient connector.
3. Plug the power cord into the AC power outlet (AC mains).
Warning: 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.
2.2.2 Downloading the app
1. Make sure the mobile device is connected to the Internet.
2. Open the app store and search for the app.
3. Touch the app icon to download the app onto the mobile device.
12
4. Install the app.
5. Touch the app icon to open it.
6. Follow the instructions in the app to complete the installation.
2.2.3 Pairing the patient connector with the app
The patient connector uses a Bluetooth connection to communicate with the mobile
device. You will need to pair each patient connector to the mobile device. You can
have up to 20 patient connectors paired to one app.
1.
2.
3.
4.
5.
6.
Enable Bluetooth on the mobile device, if it is not enabled.
Open the app.
Touch CONTINUE in the app.
Locate the 8-digit security key code on the back of the patient connector.
Enter the security key code and touch CONTINUE.
Turn on the patient connector by pressing the button. The Bluetooth light on the
patient connector will flash when it is communicating with the mobile device.
7. Accept the Bluetooth pairing request on the mobile device.
8. Complete the configuration steps in the app.
2.2.4 Turning on the patient connector
1.
2.
3.
4.
Locate the button on the top of the patient connector.
Press and release the button.
Complete the task.
The patient connector will turn off after 1 minute of inactivity. If the patient
connector is not yet paired, it will turn off after 2 minutes. You can also hold the
button down for 3 seconds to turn the patient connector off manually.
2.2.5 Attaching the tether kit
The tether kit provides a way to attach the patient connector to the power cord. This
is an optional configuration.
1. Locate the plug over the power supply cover on the bottom of the patient
connector.
2. Use the Medtronic-supplied Allen wrench to remove the screw.
3. Slide the cable retainer over the power supply plug of the power cord.
4. Attach the power supply plug side of the power cord to the patient connector.
5. Insert the screw into the bottom of the cable retainer and tighten the screw
using the Allen wrench.
Caution: Do not overtighten the screw when attaching the tether kit.
Warning: Use the Medtronic-supplied components only. Use of unapproved
components may reduce device effectiveness or impact user or patient safety.
2.2.6 Troubleshooting potential interference
To address possible harmful interference between the patient connector and other
devices, which would result in reduced quality of service, you are encouraged to
take one or more of the following measures to address the situation:
•
•
•
•
Reorient or relocate the devices.
Increase the separation between the patient connector and the devices.
Connect the equipment to an outlet on a different circuit.
Consult Medtronic for help.
13
3 Conducting a patient session
3.1 Position the patient connector
For an implantable device, the patient connector should be held directly against the
patient’s skin. The face of the patient connector must be parallel to and typically
within 5 cm of the implantable device. Optimum position of the patient connector
may not be directly centered over the implantable device. The distal end of the
patient connector should be placed over the device with the device under the
antenna. For best telemetry performance, do not use the patient connector close to
sources of electrical noise.
3.2 Communicating with an implanted device
1. Touch the app icon to open it.
2. Follow the instructions in the app to start communicating with the device.
3. If the patient connector isn’t already on, turn on the patient connector by
pressing the button.
4. Hold the patient connector over the implanted device until the communication
is complete. Communication can take up to 5 minutes.
5. Follow the instructions in the app to complete the task.
4 Maintaining the patient connector
4.1 Cleaning and disinfecting the 24965 Patient Connector
Caution: Do not immerse the patient connector in water or cleaning agents. Severe
damage to the device may occur. Do not use automated machine washers. Do not
sterilize the patient connector by ethylene oxide, gamma radiation, or
steam-sterilization (autoclave). Damage may occur using these methods.
Caution: Turn the power off on the patient connector. Disconnect the power supply
cord or unplug the power supply from the wall socket if the cable retention kit is used.
Do not expose the patient connector to ethers, acetone, or chlorinated solvents.
These solvents may damage the housings or labels.
Cleaning
10% Bleach method
1. Before disinfection, clean the patient connector thoroughly using a 10% bleach
and water solution and a dampened sterile gauze pad or sponge.
2. Wipe down to remove all visible soil.
3. Allow to air dry approximately 5 minutes or until dry.
Disinfecting
Use one of the methods below:
70% Isopropyl method
1. Disinfect the patient connector by using a 70% isopropyl alcohol and a sterile
prep pad, saturated gauze pad or sponge.
2. Wipe down all external surfaces and maintain a wet or damp exposure time of
15 minutes.
3. Allow to air dry approximately 5 minutes or until dry.
10% Bleach method
14
1. Disinfect the patient connector by using a 10% bleach and water solution and
a sterile saturated gauze pad or sponge.
2. Wipe down all external surfaces and maintain a wet or damp exposure time of
15 minutes.
3. Allow to air dry approximately 5 minutes or until dry.
4.2 Software updates
Software updates will be pushed automatically to the patient connector when you
start a communication session. Updates can take up to 5 minutes. You must wait
until the update is complete before you can continue with the session.
4.3 Specifications
Table 2. Patient Connector specifications
Standards (The patient connector complies with the following:)
Radio frequency wireless specifications and applicable standards
EMC
EN / IEC 60601-1-2
EN 300 328
EN 301 489
EN 302 195
EN 55022 Class B
EN 55024 Class B
Radio
FCC CFR 47
RSS-210
R&TTE Directive 1999/5/EC
Patient safety
UL/CUL 60601-1, Type BF applied part
EN 60601-1, Class 2, continuous operation, Type
BF
AC power requirement
Voltage
100–240 VAC nominal
Frequency
50/60 Hz nominal
Battery
Type
Li-polymer, rechargeable
Capacity
1500 mAh
Charge duration
Standby: 15 days
Operating: 2 hours (typical)
Voltage
3.7 V
Power supply
AC/DC adapter in
100–240 VAC @ 50/60 Hz
100-240 VAC 0.5A 50-60 Hz
AC/DC adapter out
5 V @ 5.3 A
5 VDC 3 A
Electrical safety requirements per IEC 60601-1:1988, Clause 19
Enclosure leakage current ≤ 0.1 mA
Patient leakage current A.C. ≤ 0.1 mA
Patient auxiliary current
≤ 0.01 mA
D.C.
Patient auxiliary current
≤ 0.1 mA
A.C.
15
Table 2. Patient Connector specifications (continued)
Electrical safety requirements per IEC 60601-1:2005, Clause 8.7
Touch leakage current
≤0.1 mA
Patient leakage current A.C. ≤0.1 mA
Patient auxiliary current
≤ 0.01 mA
D.C.
Patient auxiliary current
≤0.1 mA
A.C.
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) - AMD
7643: July 1993; AMD 10931: August 2000
Ingress
This product complies with international electrical
safety rating IP22 with regard to ingress of dust,
other foreign objects, and water as required by IEC
60601-1.
Physical dimension and weight
Height
14 cm
Width
7.2 cm
Depth
3.2 cm
Weight
.18 kg
Temperature limits
Operating
15 °C to 35 °C
Storage
- 20 °C to 60 °C
Transport
- 30 °C to 70 °C
Humidity limits
Operating
75%
Storage
95% at 35 °C
Storage Transport
93% at 35 °C
Altitude
Maximum
3000 m
Connectivity and controls
Bluetooth 2.1 and 4.0
Frequency range
2.4 GHz
Output power
Less than 10 mW EIRP
Expected service life
5 years
4.3.1 Expected service life
The patient connector has an expected service life of 5 years. If you notice
decreased operational time between battery charges or the battery no longer holds
its charge, contact Medtronic to get a replacement patient connector.
4.3.2 Disposal of the patient connector
Return the patient connector to Medtronic for proper disposal.
16
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636
© 2014 Medtronic, Inc.
M999999A
2014-11-20
*M999999A*
Europe/Middle East/Africa
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
Technical manuals
www.medtronic.com/manuals

---

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