St Jude Medical SJMRFC IPG with Bluetooth radio User Manual
St. Jude Medical IPG with Bluetooth radio
User Manual
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Implantable Pulse Generator
Proclaim™ IPG
Clinician's Manual
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of
its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude
Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.
For a listing of patents for St. Jude Medical neuromodulation products, visit http://patent.sjmneuro.com.
Contents
Prescription and Safety Information ........................................................................... 1
Intended Use .................................................................................................................... 1
Indications for Use ............................................................................................................ 1
Contraindications............................................................................................................... 1
Warnings .......................................................................................................................... 1
Precautions ....................................................................................................................... 2
Adverse Effects.................................................................................................................. 3
Product Description................................................................................................... 3
Package Contents.............................................................................................................. 4
Identifying the IPG ............................................................................................................. 4
Directions for Use...................................................................................................... 5
Creating an IPG Pocket ...................................................................................................... 5
Connecting a Lead or Extension to the IPG .......................................................................... 5
Implanting the IPG ............................................................................................................ 7
Replacing the IPG ............................................................................................................. 8
Disposing of Explanted Components ................................................................................... 8
Checking the Status of the IPG Battery....................................................................... 8
Technical Support ..................................................................................................... 9
Appendix A: Product Specifications ........................................................................... 9
Storage Specifications ........................................................................................................ 9
Product Materials .............................................................................................................. 9
IPG Specifications ........................................................................................................... 10
Appendix B: System Components and Accessories .................................................. 11
IPGs ............................................................................................................................... 11
Programmers and Controllers ........................................................................................... 11
Leads and Extensions ...................................................................................................... 11
Trial System .................................................................................................................... 12
Appendix C: Regulatory Statements ......................................................................... 12
Disposal Guidelines for Battery-Powered Devices .............................................................. 12
Statement of FCC Compliance .......................................................................................... 12
Statement of Compliance With License-Exempt RSS Standard (Canada) ............................. 13
Identification Information for Product Registration ............................................................. 13
Wireless Technology Information ...................................................................................... 13
Radio Transmitter, Cables, Transducers ........................................................................... 14
Quality of Service for Wireless Technology ......................................................................... 14
Appendix D: Symbols and Definitions....................................................................... 15
Additional Symbols for Product Labels .............................................................................. 16
Appendix E: CE Mark Date ...................................................................................... 16
Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use
This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve
structures. The system is intended to be used with leads and associated extensions that are
compatible with the system.
Indications for Use
This neurostimulation system is indicated as an aid in the management of chronic, intractable
pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following:
failed back surgery syndrome and intractable low back and leg pain.
Contraindications
This system is contraindicated for patients who are unable to operate the system or who have
failed to receive effective pain relief during trial stimulation.
Warnings
The following warnings apply to these components.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks
or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI). Patients with an implanted neurostimulation system should
not be subjected to MRI because the electromagnetic field generated by an MRI may damage the
device electronics and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic
ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system
and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or
death.
Diathermy is further prohibited because it may also damage the neurostimulation system
components. This damage could result in loss of therapy, requiring additional surgery for system
implantation and replacement. Injury or damage can occur during diathermy treatment whether
the neurostimulation system is turned on or off.
Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an
implanted neurostimulation system. Contact between an active electrode and an implanted IPG,
lead, or extension can cause severe injury to the patient. If use of electrocautery is necessary, first
turn off the neurostimulation system.
Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction
between a neurostimulation system and an implanted cardiac system, such as a pacemaker or
defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing
operation of an implanted cardiac system, causing the cardiac system to respond inappropriately.
To minimize or prevent the implanted cardiac system from sensing the output of the
neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify
that the neurostimulation system is not interfering with the functions of the implanted cardiac
system; and (3) avoid programming either device in a unipolar mode (using the device’s can as
an anode) or using neurostimulation system settings that interfere with the function of the
implantable cardiac system.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been
established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy
and nursing have not been established.
Device components. The use of non-St. Jude Medical components with this system may result in
damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns
could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain
batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG
because explosion or fire may result.
Precautions
The following precautions apply to these components.
General Precautions
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of
chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugs
and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation
might require that the device be explanted.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public
environments can generate EMI that is strong enough to interfere with the operation of a
neurostimulation system. Patients should avoid getting too close to these types of EMI sources,
which include the following examples: commercial electrical equipment (such as arc welders and
induction furnaces), communication equipment (such as microwave transmitters and high-power
amateur transmitters), high-voltage power lines, and some medical procedures (such as
therapeutic radiation and electromagnetic lithotripsy).
Theft detectors and metal screening devices. Certain types of antitheft devices, such as those
used at entrances or exits of department stores, libraries, and other public establishments, and
airport security screening devices may affect stimulation. Patients who are implanted with
nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may
experience a momentary increase in their perceived stimulation, which has been described by
some patients as uncomfortable or jolting. Patients should use caution when approaching such a
device and should request assistance to bypass the device. If they must proceed through the
device, patients should turn off the IPG and proceed with caution, being sure to move through the
detector quickly.
Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients
should avoid placing mobile phones directly over the system.
Sterilization and Storage
Single-use, sterile device. The implanted components of this neurostimulation system are
intended for a single use only. Sterile components in this kit have been sterilized using ethylene
oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction
into the sterile field. Do not resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact
with liquids of any kind.
Handling and Implementation
Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use
the system if the use-before date has expired.
Care and handling of components. Use extreme care when handling system components prior to
implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use
of sharp instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package or components
show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any
reason. Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested after
implantation and before the patient leaves the surgery suite.
Device modification. The equipment is not serviceable by the customer. To prevent injury or
damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude
Medical for service.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an
electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If
lithotripsy must be used, do not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause
mechanical damage to an implanted neurostimulation system if used directly over the implanted
system.
External defibrillators. The safety of discharge of an external defibrillator on patients with
implanted neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted
neurostimulation system, although no testing has been done and no definite information on
radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt
machines, and linear accelerators. If radiation therapy is required, the area over the implanted
IPG should be shielded with lead. Damage to the system may not be immediately detectable.
Adverse Effects
In addition to those risks commonly associated with surgery, the following risks are associated
with implanting or using this IPG:
Unpleasant sensations or motor disturbances, including involuntary movement, caused by
stimulation at high outputs (If either occurs, turn off your IPG immediately.)
Stimulation in unwanted places
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
Persistent pain at the IPG site
Seroma (mass or swelling) at the IPG site
Allergic or rejection response to implant materials
Implant migration or skin erosion around the implant
Battery failure
Product Description
This implantable pulse generator (IPG) is an electronic device designed to be connected to one or
more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed
battery within a titanium case and uses microelectronic circuitry to generate constant-current
electrical stimulation. The IPG can deliver stimulation with a single program or with multiple
programs. Each program can provide stimulation to a single anatomical area or to multiple areas.
The IPG communicates wirelessly with system programmers and controllers, and IPGs are
available in small and large sizes to accommodate different power needs. Some models can
receive software upgrades after implantation to provide patients with additional features as
approved by the respective regulatory agencies. To upgrade features on the IPG, a system
programmer is needed.
For more information about IPG features and specifications, see the appropriate appendix in this
manual.
NOTE: For more information about the neurostimulation system, see the clinician’s
programming manual for this system.
NOTE: In this document, the term "clinician programmer" refers to the St. Jude
Medical™ Clinician Programmer device, "patient controller" refers to the St. Jude
Medical Patient Controller device, "clinician programmer app" refers to the St. Jude
Medical Clinician Programmer software application (app), and "patient controller app"
refers to the St. Jude Medical Patient Controller app.
Package Contents
In addition to the product documentation, the IPG kit contains the following items:
1 IPG (see the appendix in this manual for model numbers)
1 pocket sizer
1 torque wrench (Model 1101)
2 port plugs (Model 1111)
Identifying the IPG
Before implanting the IPG, you can view the model number engraved on the IPG. After
implantation, you can identify the IPG using a radiopaque identification tag that you can view with
standard X-ray procedures. The tag, which is located in the lower left corner of the IPG when the
logo side of the IPG is facing toward you, contains a code in the following format: SJMLN. SJM
designates St. Jude Medical as the manufacturer; LN is a letter and a number combination that
identifies the model family (see the following figure).
For the Proclaim™ IPG, the code is SJM A1. To determine the exact model IPG that is implanted,
use the clinician programmer app to communicate with the IPG and view IPG information. See the
clinician’s manual for the clinician programmer for instructions.
Figure 1. Location of the IPG code on a small IPG (left) and large IPG (right)
Directions for Use
Read this section carefully for suggested directions for use related to the IPG. For directions for
use for other system components not covered in this document, see the clinician’s manual for the
appropriate device.
NOTE: Before the surgical procedure, set up communication between the clinician
programmer and the IPG while the IPG is in its sterile packaging to ensure that it is
functional. If the IPG has never established communication with a programmer, you
must first activate the IPG for communication ("wake up" the IPG) by holding a magnet
over the IPG for 8 seconds.
Creating an IPG Pocket
The following steps outline the suggested procedure to create an IPG pocket:
1.
Determine the site for the IPG, ensuring that the lead is long enough to reach the pocket and
provide a strain relief loop.
NOTE: The IPG should be located in an area that the patient can easily reach with the
programming wand. Common sites for implantation are: along the midaxillary line, in
the upper buttock along the posterior axillary line (taking care to avoid the belt line),
and in the area over the abdomen just below the lowermost rib. To ensure a flat area is
selected, you can mark a flat area prior to the surgical procedure while the patient is in
a sitting position.
2.
3.
CAUTION: Do not place the IPG deeper than 4.0 cm (1.57 in) because the
clinician programmer may not communicate efficiently with the IPG.
Create the pocket so that the IPG is parallel to the skin surface and no deeper than 4.0 cm
(1.57 in) below the skin surface.
Insert and remove the pocket sizer to ensure that the pocket is large enough to
accommodate the IPG, allowing enough extra room for a strain relief loop for each lead or
extension.
Connecting a Lead or Extension to the IPG
The following steps outline the suggested guidelines to connect a lead or extension to the IPG:
CAUTION: Do not connect a lead or extension with body fluid or saline residue on
its contacts because corrosion can occur and cause failure of the system.
1.
If any of the lead or extension contacts came in contact with body fluid or saline, thoroughly
clean the contacts with sterile deionized water or sterile water for irrigation and dry them
completely.
CAUTION: Observe these cautions when performing the following step:
Do not bend the lead sharply or it may be damaged.
Do not loosen the setscrew in the connector more than a quarter turn at a time
while trying to insert the lead. Retracting the setscrew too far can cause the
setscrew to come loose and make the connector assembly unusable.
2.
Using clean gloves, carefully slide the proximal end of the lead or extension into the IPG
header until it stops. When the lead or extension is correctly inserted, the contact bands on
the lead or extension are fully inside the connector assembly and the windows between each
of the header contacts are clear.
Figure 2. Insert the lead or extension fully into the IPG header
1.
2.
3.
4.
3.
Fully inserted
Not fully inserted
Window between each header contact is clear
Window between each header contact is
partially blocked by contact band
CAUTION: Use only the torque wrench that is compatible with the IPG or the
device may be damaged and rendered unusable.
Insert the torque wrench through the septum and tighten the setscrew, turning it clockwise
until the wrench clicks.
Figure 3. Tighten the setscrew clockwise
4.
5.
Remove the torque wrench and check the septum to ensure that it closed. If the septum did
not close, gently reseat the septum flaps.
If implanting two leads, repeat the previous steps. If implanting a single lead only, insert the
header port plug into the unused port, and use the torque wrench to tighten the setscrew
until it clicks.
Figure 4. Insert the port plug
Implanting the IPG
The following steps outline the suggested procedure to implant the IPG:
1.
Place the IPG into the IPG pocket with the logo side facing the skin surface and at a depth
not to exceed 4.0 cm (1.57 in).
NOTE: By implanting the IPG with the logo side facing the skin surface, you enhance
the IPG's ability to detect a magnet.
Figure 5. Place the IPG in the pocket
2.
3.
4.
5.
Carefully coil any excess lead or extension behind the IPG in loops no smaller than 2.5 cm
(1 in) in diameter to provide strain relief for the lead or extension and IPG connection.
CAUTION: Do not bring the suture needle in contact with an IPG, lead, or
extension, or the component may be damaged.
To stabilize the IPG within the pocket, pass suture through the holes at the top of the IPG
header and secure it to connective tissue.
Check the entire system by fluoroscopy before closing to ensure proper positioning of the
lead or leads and that it is straight, with no sharp bends or kinks.
Use the clinician programmer app to communicate with the IPG and perform intraoperative
testing to confirm that the system is operational. See the clinician's manual of the clinician
programmer app for instructions.
NOTE: IPG output may not be identical to that of the trial stimulator at the same
settings.
6.
Ensure that the IPG is away from the pocket incision suture line, close the pocket incision,
and apply the appropriate dressings.
Figure 6. Close the pocket incision
Replacing the IPG
The following steps outline the suggested procedure to replace an IPG:
1.
Turn off the IPG or verify that it is turned off.
CAUTION: Exercise care when using sharp instruments or electrocautery around
leads or extensions, or they may be damaged.
2.
Open the IPG implant site per normal surgical procedure.
3.
Insert the torque wrench through the septum of the IPG header and loosen the setscrew by
turning it counterclockwise.
CAUTION: When performing the following step, do not bend the lead or extension
sharply; or it may be damaged.
4.
Gently remove the lead or extension from the IPG header; then clean and dry all
connections, ensuring they are free of fluid and tissue.
5.
To complete the IPG replacement procedure, see the following sections: “Connecting a Lead
or Extension to the IPG” (page 5) and “Implanting the IPG” (page 7).
Disposing of Explanted Components
Explanted components should be returned to St. Jude Medical for proper disposal. To return an
explanted component, place it in a container or bag marked with a biohazard label and coordinate
the return with your St. Jude Medical™ representative or Technical Support.
Checking the Status of the IPG Battery
The IPG contains a nonrechargeable battery. The amount of time that the battery will provide
active stimulation depends on the patient’s stimulation settings and daily usage time. To check
the status of the IPG battery, use the clinician programmer app or patient controller app. The
clinician programmer app can also estimate how much time remains until the IPG battery can no
longer support stimulation. For more information about these functions, refer to the clinician’s
programming manual and the user’s guide for the patient controller app. For more information
about the estimated longevity of the IPG battery, see the product specifications in the appropriate
appendix in this manual.
NOTE: For more accurate measurements of the end of the IPG battery’s life, wait at
least 8 days after initial communication between the IPG and the clinician programmer
app.
The following information provides general guidelines for the battery status:
The battery status icon on the clinician programmer app or patient controller app shows a
decreasing fill as the batteries are used.
A warning will appear on the clinician programmer app or patient controller app when the
battery is critically low.
Stimulation will automatically stop when the battery cannot support stimulation.
Technical Support
For technical questions and support for your St. Jude Medical™ neuromodulation product, use
the following information:
+1 972 309 8000
+1 800 727 7846 (toll-free within North America)
For additional assistance, call your local St. Jude Medical representative.
Appendix A: Product Specifications
NOTE: Not all models are available in all countries. Contact your local representative for
more information.
Storage Specifications
Store the components according to the following conditions.
Table 1. Storage conditions for components
Temperature
-20°C–60°C (-4°F–140°F)
Humidity
10%–90% (noncondensing)
Pressure
70–150 kPa (10.2–21.8 psi)
Product Materials
Table 2. Product materials for IPG kit
Component
Material
IPG
Pocket sizer
Port plug
Titanium, silicone rubber
Polybutylene terephthalate
Polysulfone
IPG Specifications
The Proclaim™ IPGs have the following physical specifications.
Table 3. IPG specifications
Model
MRI Status
3660
3662
Untested
Yes
Untested
No
3665
3667
Height
5.55 cm (2.19 in)
6.68 cm (2.63 in)
Length
4.95 cm (1.95 in)
5.02 cm (1.98 in)
Thickness
1.34 cm (0.53 in)
1.35 cm (0.53 in)
Weight
48.9 g (1.7 oz)
58.3 g (2.1 oz)
Volume
30.4 cm3 (1.9 in3)
38.6 cm3 (2.4 in3)
4.5 years
6.5 years
Estimated battery
longevity (nominal
settings)*
Power source
Upgradeable
Features
Carbon monofluoride/silver vanadium
oxide cell
Connector
strength
Exceeds EN 45502-1 requirements
Program storage
capacity
16 programs with 8 stim sets each
* Battery longevity was estimated using the following nominal settings 12 hours per day: 50-Hz
frequency, 225-μs pulse width, and 5-mA amplitude at 500-ohms impedance. For information on
how additional settings may impact the longevity of the device, please contact Technical Support.
The IPG has the following operating parameters.
Table 4. Operating parameters for the IPG
Parameter
Tonic Range
Steps
Burst Range
Steps
Pulse width
20–1000 µs
10 µs
(20–500 µs range)
50 µs
(500–100 µs
range)
20–1000 µs
50 µs
Frequency
2–200 Hz
200–500 Hz
500–1200 Hz
2 Hz
10 Hz
20 Hz
—
—
—
—
—
—
Burst rate
frequency
—
—
10–60 Hz
10 Hz
10
Parameter
Tonic Range
Steps
Burst Range
Steps
Intraburst
frequency
—
—
250–500 Hz
10 Hz
500–1000 Hz
20 Hz
Amplitude
0–25.5 mA
0–12.75 mA
0.05–1.0 mA
0.1–1.0 mA
NOTE: The number of stim sets in use for a tonic program governs the maximum frequency
(1200/number of stim sets).
NOTE: The maximum current depends on the impedance, frequency, and pulse width settings.
Appendix B: System Components and Accessories
The Proclaim™ neurostimulation system includes the following components.
NOTE: Not all models are available in all countries. Contact your local representative for more
information.
IPGs
3660
3662
3665
3667
Proclaim™ 5 Elite IPG
Proclaim™ 7 Elite IPG
Proclaim™ 5 IPG
Proclaim™ 7 IPG
IPG Accessories
1101 Torque wrench
1111 Port plug
Programmers and Controllers
3874 St. Jude Medical™ Clinician Programmer App
3875 St. Jude Medical™ Patient Controller App
Programmer and Controller Accessories
1210 Patient magnet
3884 SCS patient manual and magnet
Leads and Extensions
3100-series percutaneous leads
3200-series paddle leads
3300-series extensions
Lead and Extension Accessories
1100-series stylets
1102 Guide wire for percutaneous leads
1103 Introde-AK™ lead introducer
1105 Lead anchor, butterfly
1106 Lead anchor, long
1109 Strain relief
11
1112
1114
1116
1120
1192
1194
1701
Tunneling tool, 12 in
Epidural needle, 14 gauge, 4 in (10 cm)
Epidural needle, 14 gauge, 6 in (15 cm)
Tunneling tool, 20 in
Swift-Lock™ anchor
Cinch™ anchor
SCS accessory kit
Trial System
3599 St. Jude Medical™ External Pulse Generator
Trial System Accessories
1203
1212
1213
1214
1216
1218
1917
3014
3032
Cleaning cloths
Coin cell batteries
Pouch with adhesive (5)
Pouch without adhesive and belt (5)
EPG header cap
Carrying case
Battery door
Multilead trial cable
External pulse generator, 2-port header
Appendix C: Regulatory Statements
This section contains regulatory statements about your product.
Disposal Guidelines for Battery-Powered Devices
This device contains a battery and a label is affixed to the device in accordance with European
Council directives 2002/96/EC and 2006/66/EC. These directives call for separate collection and
disposal of electrical and electronic equipment and batteries. Sorting such waste and removing it
from other forms of waste lessens the contribution of potentially toxic substances into municipal
disposal systems and into the larger ecosystem. Return the device to St. Jude Medical at the end
of its operating life.
Statement of FCC Compliance
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses, and can
radiate radiofrequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
12
Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Consult the dealer or an experienced radio/TV technician for help.
Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause
undesired operation.
Modifications not expressly approved by the manufacturer could void the user’s authority to
operate the equipment under FCC rules.
Statement of Compliance With License-Exempt RSS Standard
(Canada)
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the
device.
Identification Information for Product Registration
This device has a label that contains, among other information, a product identifier in the following
format:
Table 5. Registration identification information
Identifier Type
Registration Identifier
FCC registration number
Industry Canada (IC) registration number
RIASJMRFC
IC: 8454A-M3660123
Wireless Technology Information
The following table summarizes the technical details of the Bluetooth® low energy (BLE)
technology as it is implemented in the device.
Table 6. Bluetooth low energy information
Antenna type
Embedded patch antenna in header
Antenna dimensions
8.1 mm x 5.1 mm x 4.9 mm
Modulation
GFSK
Magnetic field strength (at 2 m distance)
16.3 µA/m
Electric field strength (at 2 m distance)
6.1 mV/m
Output power (EIRP*)
1 mW (0 dBm) typical, 10 mW (+10 dBm)
maximum
Range
1–2 m typical
Center frequency
2.44 GHz
Channel
40 logical channels
Bandwidth
2 MHz per channel
13
Data flow
Bi-directional
Protocol
BLE
*EIRP = Equivalent isotropically radiated power
Radio Transmitter, Cables, Transducers
The device contains a radio transmitter/receiver with the following parameters.
Radio transmitter parameters:
Frequency (range): 2.4000 to 2.4835 GHz
Bandwidth (-15dB): 2.398 to 2.4855 GHz
Channel: 40 logical channels using AFH
Modulation: GFSK
Radiated output power: 10 mW (+10 dBm) maximum
Magnetic field strength (at 2 m distance): 16.3 µA/m
Duty cycle: Variable, but low (<5%)
Semi-duplex capability
The radio receiver in the device is using the same frequency and bandwidth as the transmitter.
Cables and transducers:
Cables and transducers are not used during normal use of the device nor while programming the
device.
Quality of Service for Wireless Technology
Bluetooth® low energy (BLE) wireless technology enables communication between the generator
and the patient controller. The requirements for the quality of service (QoS) vary depending on the
use environment (operating room, recovery room, and home environment).
After the patient controller is paired with a generator, the Bluetooth symbol is visible on the patient
controller in the upper right-hand corner of the screen. When the BLE connection is not active,
the symbol appears dimmed.
Other requirements include a semi-duplex transmission with a required acknowledge, a
transmission latency in each direction (2x), and a receive-to-transmit mode (RX-to-TX) time. Data
is resent if not sent successfully. Each key press may transmit up to 8 data packets, depending on
the number of packets that need to be transmitted (i.e., if there is only one packet to transmit,
only one packet will be transmitted).
Wireless Security Measures
The wireless signals are secured through device system design that includes the following:
The generator will encrypt its wireless communication.
Only one patient controller or clinician programmer may communicate with the generator at
the same time.
A unique key for each unit that is checked during each transmission.
Built-in pairing that specifies valid and legitimate pairing among units.
Proprietary authentication in addition to the pairing procedure specified in Bluetooth low
14
energy, which includes an element of proximity.
A proprietary algorithm that detects and prevents an unauthorized user from attempting to
pair with the generator.
Troubleshooting for Wireless and Coexistence Issues
If you experience issues with the wireless communication between the generator and the clinician
programmer or patient controller, try the following:
Decrease the distance between the devices
Move the devices so they share line of sight
Move the devices away from other devices that may be causing interference
Wait a few minutes and try connecting again
Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone)
at the same time
NOTE: Wireless communications equipment, such as wireless home network devices,
mobile and cordless telephones, and tablets, can affect the device.
Appendix D: Symbols and Definitions
The following symbols may be used in this document and on some of the products and
packaging:
Symbol
Description
Caution, Consult Accompanying Documents
Consult instructions for use
Follow instructions for use on this website
Denotes that the device contains a radio-frequency (RF) transmitter, which may
cause RF interference with other devices near this device.
Denotes single use only
Do not resterilize
Denotes expiration date
Denotes date of manufacture
Denotes temperature limits for storage conditions
Denotes humidity limits
Denotes pressure limits
Do not use if the product sterilization barrier or its packaging is compromised
15
Symbol
Description
Catalog number
Manufacturer
Contents quantity
Code that uniquely identifies an inventory item
Serial number
Batch code
Prescription only
Ethylene oxide gas sterilization
Authorized European representative
European conformity, affixed in accordance with the relevant provisions of AIMD
directive 90/385/EEC and R&TTE directive 1999/5/EC. Hereby, St. Jude Medical
declares that this device is in compliance with the essential requirements and other
relevant provisions of these directives.
Complies with AS/NZS standards: AS/NZS 4268 (Australia and New Zealand)
Complies with New Zealand’s Radiocommunications (Radio Standards) Notice 2010
in accordance with section 133 of the Radiocommunications Act 1989 and
regulation 32 of the Radiocommunications Regulations 2001
Complies with Japanese radio standard ARIB T-66 V3.6
Additional Symbols for Product Labels
Symbol
Description
Torque wrench
Port plug
Implantable pulse generator
Appendix E: CE Mark Date
Table 7. Year in which CE mark was awarded
Model
Year
1101
1111
3660, 3662, 3665, 3667
1999
2006
2015
16
Manufacturer:
St. Jude Medical
6901 Preston Road
Plano, Texas 75024
USA
+1 972 309 8000
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
sjm.com
*100125493-3*
MAR 2015
37-6413
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
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