St. Jude Medical™ External Pulse Generator Model 3599

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. © 2016 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 Indications for Use .................................................................................................................... 1 Contraindications....................................................................................................................... 1 Warnings .................................................................................................................................. 2 Precautions ............................................................................................................................... 4 Adverse Effects ......................................................................................................................... 7

Product Description .......................................................................................................... 8 Overview of the EPG and EPG Header .......................................................................................10 Package Contents.....................................................................................................................12

Getting Started ................................................................................................................ 13 Overview of the EPG Procedure .................................................................................................13 Replacing the EPG Batteries .....................................................................................................14 Checking the Status of the EPG Batteries ...................................................................................18 Setting Up Communication Between the EPG and the Clinician Programmer and Patient

Controller ..............................................................................................................................19 EPG Indicator Light ...................................................................................................................20 Starting and Stopping Stimulation ..............................................................................................20

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Using the EPG ................................................................................................................ 23 Compatibility Guidelines ........................................................................................................... 23 Connecting the Multilead Trial Cable to the EPG ........................................................................ 24 Disconnecting the Multilead Trial Cable from the EPG ............................................................... 26 Securing the Leads or Extensions ............................................................................................. 26 Connecting the EPG Header to the EPG .................................................................................... 26 Connecting the Leads or Extensions to the EPG Header ............................................................. 28 Securing the EPG .................................................................................................................... 30

Programming the EPG .................................................................................................... 31 Caring for the EPG .......................................................................................................... 31

Handling the EPG .................................................................................................................... 31 Cleaning the EPG .................................................................................................................... 32 Storing and Transporting the EPG ............................................................................................. 32

Service and Ordering Information .................................................................................... 34 Technical Support ................................................................................................................... 34 Ordering Information................................................................................................................ 34

Appendix A: Product Specifications ................................................................................. 36 EPG with Header ..................................................................................................................... 36

Appendix B: Regulatory Statements ................................................................................ 38 Battery Disposal Guidelines ...................................................................................................... 38

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Statement of FCC Compliance ...................................................................................................38 Statement of Compliance With License-Exempt RSS Standard (Canada) ......................................39 Statement of Compliance With Interference-Causing Equipment Standard (Canada) ....................39 Identification Information for Product Registration ......................................................................39 Product Classification Statement (CISPR 11, Class B).................................................................40 Wireless Technology Information ...............................................................................................40 Radio Transmitter, Cables, Transducers ....................................................................................41 Quality of Service for Wireless Technology ..................................................................................42

Appendix C: Electromagnetic Compatibility Guidelines ..................................................... 45 Radio Frequency Information ....................................................................................................54

Appendix D: Symbols and Definitions .............................................................................. 55

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Prescription and Safety Information Read this section to gather important prescription and safety information.

Indications for Use The St. Jude Medical™ invisible neuromodulation trial 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 any of the following: failed back surgery syndrome and intractable low back and leg pain.

The St. Jude Medical™ invisible neuromodulation trial system is intended to be used externally with St. Jude Medical-approved trial leads and extensions to deliver trial stimulation for a maximum of 30 days.

Contraindications This neurostimulation system is contraindicated for patients who are unable to use the system.

Neurostimulation should not be used on patients who are poor surgical risks, such as those with multiple illnesses or active general infections.

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Warnings The following warnings apply to these components.

Other system components. Refer to the individual system component manuals for additional warnings and precautions related to those devices.

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.

Explosive or flammable gases. Do not use the stimulator in an environment where explosive or flammable gas fumes or vapors are present, including hyperbaric chambers. The operation of the stimulator could cause them to ignite, causing severe burns, injury or death.

Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an implanted neurostimulation device. Contact between an active electrode and an implanted lead or extension can cause direct stimulation of the tissue at the electrode site and cause severe injury to the patient. If use of electrocautery is necessary, first turn off the neurostimulation system.

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Implanted cardiac system. 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 functions of the implantable cardiac system.

Magnetic resonance imaging (MRI). Patients with an EPG should not be subjected to MRI. Even if the leads are removed the patient should not have an MRI if any part of a lead is still implanted.

Lead movement. Patients should avoid bending, twisting, stretching, or lifting objects over five pounds for six to eight weeks postimplantation. Extension of the upper torso or neck may cause lead movement and alter the stimulation field, resulting in overstimulation or ineffective stimulation.

Operation of machines, equipment, and vehicles. Patients should not drive or operate heavy machinery or power tools with the stimulator turned on. Postural changes or abrupt movement could cause overstimulation (jolting sensation) that might cause patients to lose control of their vehicle or equipment.

Postural changes. Changes in posture or abrupt movements can change the level of stimulation and potentially cause unpleasant sensations. Patients should turn stimulation off or lower the amplitude

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before stretching, lifting their arms over their head, or exercising. If unpleasant sensations occur, turn off stimulation.

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.

System 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.

Power supply. Use only the CR2450 batteries supplied with the device. CR2450 batteries have a nominal voltage of 3V and nominal capacity of at least 600 mAh.

Precautions The following precautions apply to these components.

General Precautions

Clinician Training. Clinicians should be experienced in implanting neurostimulation devices and should have undergone sufficient 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 and inform patients to avoid showering and

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touching the bandages.

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 EPG and proceed with caution, being sure to move through the detector quickly.

Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

Handling and Implementation

Single use only. The EPG header is intended for single use only.

Exposure to liquids. Device components should be stored where they will not be exposed to liquids or excessive moisture, which can damage the package materials and components.

Care and handling of components. Use extreme care when handling system components prior to use. Excessive heat, traction, bending, and twisting, or the use of sharp instruments may damage components and cause them to fail.

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Package or component damage. Do not use the device if the package or components show signs of damage. Return any suspect components to St. Jude Medical for evaluation.

System testing. To ensure correct operation, the system should always be tested 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.

Component disposal. Dispose of the EPG header and pouch with other medical waste. Return the EPG to St. Jude Medical for safe disposal when necessary.

Hospital and Medical Environments

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of a 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, computerized tomography (CT) scans, cobalt machines, and linear accelerators. If radiation therapy is required, disconnect the EPG from the leads or extensions. Damage to the system may not be immediately detectable.

Home and Occupational Environments

Electromagnetic interference (EMI). Certain commercial electrical equipment (for example, arc welders, induction furnaces, and resistance welders), communication equipment (for example, microwave transmitters, linear power amplifiers, and high power amateur transmitters), high voltage

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power lines, and radio-frequency identification (RFID) devices may generate sufficient EMI to interfere with the operation of the neurostimulation system if approached too closely. Keep the neurostimulation system at least 10 cm (4 in) away from RFID devices.

Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients should avoid placing mobile phones directly over the system.

Adverse Effects The use of a neurostimulation system involves risks. In addition to those risks commonly associated with surgery, the following risks are also associated with use of a neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by

stimulation at high outputs (If either occurs, turn off stimulation immediately.) Undesirable changes in stimulation, which may be related to cellular changes in tissue around the

electrodes, changes in electrode position, loose electrical connections, or lead failure Stimulation in unwanted places Radicular chest wall stimulation Lead migration, causing changes in stimulation or reduced pain relief Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement

of a lead in the epidural space Cerebrospinal fluid (CSF) leakage Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant

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Persistent pain at the electrode site Seroma (mass or swelling) at the implant site Allergic or rejection response to device materials

Product Description The St. Jude Medical™ External Pulse Generator (EPG) is an external trial generator that when connected to trial neurostimulation leads delivers therapeutic stimulation to parts of the body. The EPG communicates wirelessly with system programmers and controllers.

The EPG header connects directly to the EPG for a neurostimulation trial. The EPG header can hold one or more leads or extensions with up to 16 electrodes total.

NOTE:

Patients may experience a sensation of tingling, “pins and needles,” prickling, or even burning called paresthesia. Paresthesia may be brief or it may last a long time.

NOTE:

For more information about the neurostimulation system, see the clinician’s programming manual for this system.

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NOTE:

The EPG is supplied nonsterile and is intended to be used multiple times. The EPG header is also supplied nonsterile, but is single use only.

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 app, and "patient controller app" refers to the St. Jude Medical™ Patient Controller app.

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Overview of the EPG and EPG Header Refer to the following figures for the EPG and EPG header features:

Figure 1. EPG features

1. Connector for multilead trial cable and EPG header

2. Battery compartment panel 3. Indicator light

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Figure 2. EPG header features

1. Button 2. Port 1, electrodes 1-8 3. Port 2, electrodes 9-16

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Package Contents In addition to the product documentation, the External Pulse Generator, 16 channel (Model 3599) contains the following items: 1 EPG (Model 3599) 1 EPG header cap 1 battery door

In addition to the product documentation, the External Pulse Generator, 2 Port Header (Model 3032) contains the following items: 1 EPG header 2 CR2450 Batteries Cleaning cloths 1 EPG pouch with adhesive

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Getting Started This section provides a general overview of the EPG procedure and instructions for tasks, such as replacing the batteries and setting up communication between the EPG and the clinician programmer and patient controller.

Overview of the EPG Procedure The following steps provide a general overview of the EPG procedure. Refer to the following sections for more information about each of these steps. 1. Replace the EPG batteries. 2. Set up communication between the EPG and the clinician programmer and patient controller. 3. Implant the leads or extensions. 4. Connect the leads or extensions to the multilead trial cable. 5. Connect the multilead trial cable to the EPG. 6. Test the system. 7. Disconnect the multilead trial cable from the EPG. 8. Disconnect the multilead trial cable from the leads or extensions. 9. Secure the leads or extensions and bandage the lead entry site. 10. Connect the EPG header to the EPG.

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11. Insert the leads or extensions into the EPG header. 12. Place the EPG into the pouch and secure to the patient. 13. Program the system.

Replacing the EPG Batteries The EPG uses two nonrechargeable CR2450 coin cell batteries. St. Jude Medical recommends replacing the batteries before starting a new trial and only using the batteries included in the External Pulse Generator, 2 Port Header.

NOTE:

Dispose of batteries safely. Do not treat them as household waste. Refer to the guidelines in Appendix B for more information.

To replace the batteries, follow these steps: 1. Disconnect the EPG header or multilead trial cable from the EPG if either is connected. Also, if the

EPG is communicating with the clinician programmer or patient controller, end the session. Refer to the clinician’s programming or user’s controller manual for instructions.

2. Press and slide the battery compartment panel outward to open the battery compartment and remove the panel.

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Figure 3. Battery compartment panel

3. Remove the batteries by either: - turning the EPG over so the battery compartment is facing down and lightly tapping the EPG

in the palm of your hand, or

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- pressing down on one side of the battery so the opposite side pops up, lifting the battery out, and repeating the process with the remaining battery.

4. Insert a new battery into the battery compartment, paying attention to the polarity directions provided on the inside of the battery compartment.

5. Insert the second battery into the second battery compartment.

Figure 4. Inserting batteries into the battery compartment

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6. Place the battery compartment panel flush to the EPG, lining up the tabs with the coordinating indentation.

Figure 5. Replacing the battery compartment panel

7. Slide the panel closed flush with the EPG until it snaps into place.

NOTE:

When you insert the batteries, the indicator light is solid. You must wait until the indicator light is flashing or off to set up communication.

NOTE:

If you replace the batteries but the generator battery indicator on the clinician programmer app or patient controller app indicates the batteries are low, make sure the batteries are inserted correctly.

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Checking the Status of the EPG Batteries Check the status of the EPG’s batteries using the clinician programmer app or the patient controller app. Refer to the clinician’s programming or user’s controller manual for these directions.

NOTE:

Battery life depends on usage and stimulation settings, with batteries lasting at least 14 days under nominal or practical high output settings, with 500 ohm impedance and stimulation on for 16 hours per day. (High output is based on actual patient use collected in St. Jude Medical clinical studies, not the maximum device output.)

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 batteries

are critically low. Stimulation will automatically turn off when the batteries cannot support stimulation. Replace the

EPG’s batteries to communicate with the EPG, turn stimulation on, change stimulation settings, or retrieve stimulation usage information.

NOTE:

If the batteries deplete during a trial, instruct the patient to refrain from replacing the

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batteries to avoid disturbing the bandaging and lead position.

Setting Up Communication Between the EPG and the Clinician Programmer and Patient Controller Before starting the surgical procedure, set up communication between the EPG and the clinician programmer and patient controller. The following steps outline the procedure for setting up communication. For further instructions, refer to the clinician’s programming manual. 1. Place the magnet perpendicular to and centered directly over the front of the EPG for 10 seconds.

The indicator light on the EPG will start flashing. 2. Set up communication using the clinician programmer app or the patient controller app following

the directions shown on the screen.

After setting up communication, the EPG is paired with that clinician programmer and patient controller. You will not need to pair them again unless another patient controller or more than four clinician programmers are paired to the EPG.

NOTE:

Store paired EPGs and patient controllers together to reduce the number of times you need to set up communication.

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EPG Indicator Light The indicator light on the EPG will flash for the following reasons: When batteries are inserted into the EPG When a communication session with the clinician programmer app or patient controller app is

started When the magnet is held for approximately 10 seconds over the EPG (signaling the EPG is ready

to pair with the clinician programmer or patient controller)

NOTE:

The EPG indicator light flashes faster when it is ready to pair than when batteries are inserted or a communication session is started.

Starting and Stopping Stimulation Use the clinician programmer app or the patient controller app to start or stop stimulation. You may also use the magnet (Model 1210) to start or stop stimulation if Magnet Mode is programmed to On/Off or Off.

To use the magnet, follow these steps: 1. Take the keeper bar off the magnet.

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Figure 6. Magnet and keeper bar

1. Magnet 2. Keeper bar

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2. Hold the magnet perpendicular to and centered directly over the EPG for 2 seconds.

Figure 7. Holding the magnet over the EPG

3. Remove the magnet, replace the keeper bar, and store the magnet.

CAUTION: Do not use the magnet around magnetically sensitive items to avoid damaging them.

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Using the EPG Read this section for directions for use related to the EPG and EPG header. For directions for use of other system components not covered in this document, see the clinician’s manual for the appropriate device.

NOTE:

Well in advance of the surgical procedure, set up communication between the EPG and the programmer and controller to ensure it is functional. Refer to "Setting Up Communication Between the EPG and the Clinician Programmer or Patient Controller" for instructions.

CAUTION: Before the EPG or associated components are used or secured to the patient, determine if a patient may have an allergic reaction to the materials.

Compatibility Guidelines The following table lists the trial cable and leads compatible with the EPG. For more information on these components, refer to the applicable clinician's manual.

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Table 1. Trial cable and leads compatible with the EPG

Device Model Number

Multilead trial cable 3013

Percutaneous trial leads 3046, 3066, 3086

Connecting the Multilead Trial Cable to the EPG The following information outlines the guidelines for connecting a multilead trial cable to the EPG. For further instructions, refer to the clinician’s manual for the multilead trial cable. 1. Remove the EPG header cap to expose the EPG stimulator port. 2. Carefully slide the connector end of the multilead trial cable into the EPG stimulator port.

CAUTION: The EPG is not sterile. When connecting and testing the EPG with the multilead trial cable, keep the EPG outside of the sterile field.

CAUTION: To avoid delivering jolting stimulation to the patient, turn off stimulation before plugging in the multilead trial cable.

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Figure 8. Inserting the connector into the EPG stimulator port

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Disconnecting the Multilead Trial Cable from the EPG The following steps outline the guidelines for disconnecting the multilead trial cable from the EPG. For further instructions, refer to the clinician’s manual for the multilead trial cable. 1. Turn off stimulation on the EPG using the clinician programmer app. 2. Grasp the connector end of the multilead trial cable and gently pull the connector from the EPG

stimulator port.

Securing the Leads or Extensions The following information outlines the suggested procedure for securing the leads or extensions to the patient: Secure the leads or extensions and bandage the lead entry site. For further instructions, refer to

the clinician’s manual for the applicable leads or extensions.

Connecting the EPG Header to the EPG The following information outlines the guidelines to connect the EPG header to the EPG: Align the tab indentation on the EPG header with the tab on the EPG and carefully insert the EPG

header into the EPG body until it clicks into place.

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Figure 9. Connecting the EPG header to the EPG

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Connecting the Leads or Extensions to the EPG Header The following steps outline the suggested guidelines to connect a lead or extension to the EPG header:

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: Do not bend the lead sharply or it may be damaged.

NOTE:

The EPG header comes with open ports and attached port plugs. Do not remove the port plugs from the header. If only using one lead or extension, use the lower port labeled 1-8 and insert a port plug in the unused port.

2. Push and hold the button on the EPG header to open the EPG header ports. 3. Using clean gloves, carefully slide the lead or extension into the EPG header until you reach a hard

stop and all the contact bands are fully inside the connector assembly and hidden from view.

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Figure 10. Insert the lead or extension fully into the EPG header

1. Fully inserted 2. Not fully inserted

4. Release the button to lock the lead or extension into place. 5. If applicable, repeat the previous steps to insert the remaining lead or extension. Do not disturb

the already inserted lead or extension.

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Securing the EPG The following steps outline the suggested guidelines for securing the EPG to the patient: 1. Place the EPG into the provided pouch. 2. Remove the adhesive liner on the pouch flap. 3. Use the flap to secure the leads in place and seal the pouch.

NOTE:

The EPG meets the IP22 rating when sealed in the pouch.

4. Remove the adhesive liner on the back of the pouch and press the pouch onto the patient’s skin until it is secure.

NOTE:

It is good practice to secure the EPG pouch away from the lead entry site bandaging.

NOTE:

Leave some slack in the leads or extensions when securing the EPG onto the patient.

5. Use additional medical tape to secure the pouch and leads or extensions further as needed.

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Programming the EPG Use the clinician programmer app to program the system for the trial period. For information on using the clinician programmer app for programming, refer to the clinician’s programming manual.

Caring for the EPG The EPG is an important part of the neurostimulation system. This section provides tips and other information about caring for the EPG.

Handling the EPG Do not expose the EPG to prolonged direct sunlight. Avoid exposing the EPG to sand, dust, and other environmental hazards. Do not put heavy or sharp objects on the EPG. Keep the EPG away from food and beverages, and avoid getting the EPG wet. If the EPG does get wet, do not use it. Contact Technical Support at +1 972 309 8000 for help.

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Cleaning the EPG Using two PDI Sani-Cloths, wipe the EPG for 2 minutes front and back, then allow to air dry. Once

the EPG is dry, attach the header cap.

NOTE:

Clean the EPG before attaching the header cap.

Clean the EPG by thoroughly wiping off its outer surface using the provided cleaning cloths. Do not wipe over the stimulator port. Do not submerge the EPG or use a cloth that is soaking wet.

Never use ammonia, acidic, or alkaline cleaners or organic chemicals such as paint thinner, acetone, propyl alcohol, or kerosene. They may damage surface finishes of the EPG.

Storing and Transporting the EPG Store the EPG and batteries in a cool, dry place. Do not store the EPG or batteries in your car or

garage. Transport the EPG in a carrying case. If you are carrying the EPG in a briefcase or other carrying case, make sure no objects in the case

are pressing on the device. Store paired EPGs and patient controllers together to reduce the number of times you need to set

up communication.

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At the end of a trial, disable stimulation, clean the EPG, and attach the header cap before storing the EPG.

NOTE:

During a trial store the header cap for reuse.

Figure 11. EPG header cap

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Service and Ordering Information This section provides information for contacting Technical Support and for ordering replacement parts and accessories.

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.

Ordering Information To order parts, contact Technical Support. Refer to the following list for model numbers.

Table 2. Ordering information for the EPG

Model Description

3599 External Pulse Generator, 16 channel

3032 External Pulse Generator, 2 Port Header

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Model Description

1212 Coin cell batteries

1917 Battery door

3013 MLTC

1210 Magnet

1203 Box of cleaning cloths

1216 EPG header cap

1213 Pouch with adhesive (5)

1214 Pouch without adhesive and belt (5)

1218 Carrying case

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Appendix A: Product Specifications

EPG with Header The EPG (Model 3599) and EPG header (Model 3032) has the following physical specifications.

Table 3. EPG and EPG header specifications

Height 79.8 mm (3.14 in)

Width 57.2 mm (2.25 in)

Thickness 11 mm (0.433 in)

Weight (with batteries) 44 g (1.55 oz)

Volume 44.57 cc (2.72 cu in)

Power source Nonrechargeable CR2450 coin cell

Lead or extension compatibility 2 octrode

Expected service life 5 years

Storage temperature -25°C - 70°C (-13°F - 158°F)

Operating temperature 5°C - 40°C (41°F - 104°F)

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Storage humidity up to 93% (noncondensing)

Operating humidity 15% - 93% (noncondensing)

Storage pressure 70 - 106 kPa (10.2 - 15.4 psi)

Operating pressure 70 - 106 kPa (10.2 - 15.4 psi)

Table 4. Operating parameters for the EPG

Tonic Range Steps

Pulse width 50 - 500 µs 12 - 13 µs

Frequency 2 - 200 Hz 200 - 500 Hz 500 - 1200 Hz

2 Hz 10 Hz 20 Hz

Amplitude 0 - 25.5 mA 0.1 - 1.0 mA

Stimulation output Constant current

NOTE:

The maximum current depends on the impedance, frequency, and pulse width settings.

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Appendix B: Regulatory Statements

Battery Disposal Guidelines Do not dispose of this device or its battery along with general waste. Follow local regulations for the safe disposal of the battery, and 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. Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

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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.

Statement of Compliance With Interference-Causing Equipment Standard (Canada) This ISM device complies with Canadian ICES-001.

Identification Information for Product Registration This device has a label that contains, among other information, a product identifier in the following format:

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Table 5. Registration identification information

Identifier Type Registration Identifier

FCC Registration Number PX2SJMX599EPG

Industry Canada (IC) Registration Number 8454A-SJMX599EPG

Product Classification Statement (CISPR 11, Class B) This product is class B equipment, which is intended primarily for use in the domestic environment.

Wireless Technology Information The following table summarized the technical details of the Bluetooth® low energy technology as it is implemented in the device.

Table 6. Bluetooth low energy information

Bluetooth low energy

Antenna type Embedded ceramic antenna

Antenna dimensions 4 mm x 3 mm x 1.1 mm

Modulation GFSK

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Magnetic Field Strength (at 10 m distance) 0.000145 A/m maximum

Electric Field Strength 0.055 V/m maximum

Output power (EIRP*) 1 mW (0 dBm) typical, 10 mW (+10 dBm) maximum

Range 2 meters typical

Center frequency 2.44 GHz

Channel 40 logical channels

Bandwidth 2 MHz per channel

Data-rate 5 kbit/second

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

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Channel: 40 logical channels using AFH Modulation: GFSK Radiated output power: 10 mW (+10 dBm) maximum Magnetic field strength: 0.000145 A/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 wireless technology enables communication between the EPG and the clinician programmer or patient controller. The requirements for the quality of service (QoS) vary depending on the use environment (operating room, recovery room, and home environment).

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After the clinician programmer or patient controller is paired with a generator, (Bluetooth symbol) is visible on the clinician programmer or patient controller in the upper right-hand corner. When the BLE connection is not active, the symbol is grayed out.

The raw BLE data rate is approximately 2.5 KB/sec and the effective data rate is approximately 1.5 - 2 KB/sec. 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 energy,

which includes an element of proximity. A proprietary algorithm that detects and prevents an unauthorized user from attempting to pair

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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.

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Appendix C: Electromagnetic Compatibility Guidelines The EPG, hereafter the device, is medical equipment and should be used with the following guidance.

The device requires special precautions with regard to electromagnetic compatibility (EMC) and should be used in accordance with the information provided in this manual.

The device has no essential performance, as defined by IEC 60601-1 Edition 3.1:2012. Performance of the device was maintained during immunity testing.

The device is intended for use in the electromagnetic environment specified in the following tables. The user should ensure that it is used in such an environment.

CAUTION: The device complies with the limits for medical devices contained in IEC 60601-1-2:2007-03, IEC 60601-1-2:2014-04, EN 55011:2009/A1:2010 (CISPR 11:2010), and ETSI EN 300 328 V1.8.1 (2012-06). However, the device may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to mitigate this effect by reorienting or relocating the receiving device. CAUTION: To avoid increasing emissions or decreasing immunity from a device or system, use only St. Jude Medical-approved components with this system. Do not use St. Jude Medical components with other non-St. Jude Medical devices or systems.

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Table 7. Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions CISPR 11

Group 1 The device uses RF energy for its internal and system interface functions. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable

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Table 8. Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact ±15 kV air

±8 kV contact ±15 kV air

The relative humidity should be at least 5%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

Not applicable No guidance for battery-powered devices.

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to earth

Not applicable No guidance for battery-powered devices.

Voltage dips, short interruptions IEC 61000-4-11

<5% UT 40% UT 70% UT

Not applicable No guidance for battery-powered devices.

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Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz 6 Vrms (ISM/Radio bands between 150 kHz to 80 MHz) 80% AM at 1 kHz

6 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=0.58√P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

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Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Radiated RF IEC 61000-4-3

10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

20 V/m Recommended separation distance d=0.18√P 80 to 800 MHz

d=0.35√P 800 MHz to 2.5 GHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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a Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz and 80 MHz, field strengths should be less than 3 V/m.

The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

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Table 9. Guidance and manufacturer’s declaration – proximity fields

Proximity Test IEC 60601 Test Level Compliance Level

Electromagnetic Environment Guidance

IEC 61000-4-3 385 MHz: 27 V/m @ 18 Hz pulse modulation

27 V/m Recommended separation distance d = 0.3 m 450 MHz: 28 V/m @ FM modulation 28 V/m

710 MHz, 745 MHz, 780 MHz: 9 V/m @ 217 Hz pulse modulation

9 V/m

810 MHz, 870 MHz, 930 MHz: 28 V/m @ 18 Hz pulse modulation

28 V/m

1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @ 217 Hz pulse modulation

28 V/m

2450 MHz: 28 V/m @ 217 Hz pulse modulation

28 V/m

5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @ 217 Hz pulse modulation

9 V/m

WARNING: Do not use portable RF communications equipment (including peripherals

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such as antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the EPG, including cables specified by St. Jude Medical. Otherwise, performance degradation may occur.

NOTE: For the frequency bands in the table above, use the specified recommended separation distance. The recommended separation distances in the table below apply to all other frequencies within the specified ranges.

Table 10. Recommended separation distances between portable and mobile RF communications equipment and the device

Rated Maximum Output Power of Transmitter (W)

Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz

d=1.17√P 80 to 800 MHz

d=0.18√P 800 MHz to 2.5 GHz

d=0.35√P 0.01 0.1 0.0 0.0 0.1 0.2 0.1 0.1 1 0.6 0.2 0.4

10 1.8 0.6 1.1 100 5.8 1.8 3.5

NOTE: Wireless communications equipment, such as wireless home network devices, mobile and cordless telephones, and walkie-talkies, can affect the device. Keep the device away from wireless

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communication equipment at least the distance d as listed in the 800 MHz to 2.5 GHz column in the above table. NOTE: For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Radio Frequency Information The effective radiated power is below the limits as specified in: USA: FCC 47 CFR Part 15:2012 Canada: RSS-210 Issue 8 Europe: ETSI EN 301 489 V1.9.2, ETSI EN 301 489-1 and ETSI EN 301 489-17

NOTE:

Maintain a reasonable distance between other electronic equipment and the device.

CAUTION: The ISM band used by this device has been approved by the Federal Communications

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Commission for unlicensed use. However, there is no guarantee that this device will not receive interference or that any particular transmission from this device will be free from interference.

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 this document for important safety-related information (This symbol is blue and white on the device.)

Consult instructions for use

Follow instructions for use on this website

Device contains a type BF applied part to protect you from shock. The device is internally powered and is intended for continuous operation.

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Symbol Description

Device contains a radio-frequency (RF) transmitter, which may cause RF interference with other devices near this device.

Magnetic Resonance (MR) Unsafe, an item poses unacceptable risks to the patient, medical staff, or other persons within an MR environment

Keep the device dry

Ingress protection rating for a device that is protected from the intrusion of solid foreign objects as small as 12.5 mm in diameter and is protected from vertically dripping water when the device is tilted at an angle up to 15 degrees

Single use only

Expiration date

Date of manufacture

Temperature limits for storage conditions

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Symbol Description

Humidity limits

Pressure limits

Catalog number

Manufacturer

Contents quantity

Code that uniquely identifies an inventory item

Serial number

Lot number

Prescription use only

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Symbol Description

This product shall not be treated as household waste. Instead it is the user’s responsibility to return this product to St. Jude Medical for reprocessing.

By ensuring that this product is disposed of properly, you will help prevent potential negative consequences for the environment and human health, which could be caused by inappropriate waste handling of this product. The recycling of materials will help to conserve natural resources.

For more information about how to return this product for recycling, please contact St. Jude Medical.

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.

This device is listed by Nationally Recognized Testing Laboratory (NRTL) as certified.

Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM)

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Symbol Description

This equipment is certified for type certification pursuant of Article 38-24 of the Japan Radio Law

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St. Jude Medical 6901 Preston Road Plano, Texas 75024 USA +1 972 309 8000

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11

sjm.com

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2016-03 ARTEN100146996 A