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5492000 – Pulsante® SPG Microstimulator System Patient Manual

CONTENTS

1. Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4. System Overview . . . . . . . . . . . . . . . . . . . . . . . . . 3

5. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 5

6. Warnings & Precautions . . . . . . . . . . . . . . . . . . . 5

7. Risks & Side Effects . . . . . . . . . . . . . . . . . . . . . . 8

8. Storage & Handling . . . . . . . . . . . . . . . . . . . . . . . 9

9. How to Operate Your Remote Controller . . . . 10

10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 16

11. Technical Specifications . . . . . . . . . . . . . . . . . . . 17

12. Information and Support . . . . . . . . . . . . . . . . . . . 18

1. WELCOME

Congratulations on joining the Pulsante® family! Please read this Manual before using your

Pulsante® SPG Microstimulator System. Here you will find instructions on using your Remote

Controller to deliver therapy, as well as tips on storage and warnings and precautions. These

instructions are intended for patients who have been prescribed a Pulsante® SPG Microstimulator

System by their doctor.

2. INTENDED USE OF THE PULSANTE® SPG MICROSTIMULATOR SYSTEM

In the United States, the Pulsante® SPG Microstimulator System is intended to relieve the acute pain

of cluster headache.

3. SYMBOLS

Symbols and definitions used for the Pulsante® SPG Microstimulator System:

For Prescription Use Only

Consult Operating Instructions

Model Number

Serial Number

Lot Number

Content

Use Only With

Peel Apart

Warning/Precaution

Storage and Transport Temperature Range

Keep Dry

Manufactured By

Do Not Do the following

Summary of content (19 pages)

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5492000 – Pulsante® SPG Microstimulator System Patient Manual CONTENTS 1. Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4. System Overview . . . . . . . . . . . . . . . . . . . . . . . . . 3 5. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 5 6. Warnings & Precautions . . . . . . . . . . . . . . . . . . . 5 7.
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Do not dispose devices in unsorted trash. Dispose devices per local country regulations for disposing electrical equipment Do not use device if package is opened or damaged Date of Manufacture Use By Date Symbols and definitions used only for the Pulsante® Microstimulator: Electrode Channel Constant Current Length Max Implant Depth Sterilized using Ethylene Oxide Content of unopened, undamaged package is sterile Single Use The Pulsante® Microstimulator is MR Unsafe.
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Press Up or Down Button symbol Searching For Microstimulator antenna symbol Recharge Remote symbol Low Battery symbol Depleted Battery symbol Battery Charging symbol Fully Charged Battery symbol Alert Indicator symbol Symbols and definitions used only for the Pulsante® Surgical Tools: Single Use Only Sterilized using Ethylene Oxide Symbols and definitions used for the Pulsante® Programmer Software on Clinician Programmer: Tilt Symbol indicates that the selected stimulation amplitude is not being delivere
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Figure 1: Location of the Implanted Pulsante® Microstimulator Figure 2: Pulsante® Remote Controller COMMUNICATION DISK (ROUNDED END OF REMOTE) UP BUTTON DOWN BUTTON USB PORT DISPLAY SCREEN POWER BUTTON Front View Figure 3: Pulsante® Microstimulator Side View Bottom View Figure 4: Remote Controller Charger (Coin shown for size) 4
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. PULSANTE® SPG MICROSTIMULATOR SYSTEM CONTRAINDICATIONS The Pulsante® SPG Microstimulator System should not be used in patients who have an opening to the pterygopalatine fossa of less than 1.2mm or have had metal implants or facial surgery in an area that would prevent proper placement of the Microstimulator. 6. WARNINGS & PRECAUTIONS WARNINGS Carefully read all instructions prior to use. Observe all warnings and precautions noted in this Manual.
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of another device. Do not place another device’s transmitter over the Microstimulator. It may accidentally disrupt the operation of the Microstimulator. Exposure to Moisture Do Not use your Remote Controller to activate your Microstimulator while showering, swimming, or during other activities where the Remote Controller may get wet. The Remote Controller is not waterproof and should be kept dry to avoid damage. PRECAUTIONS Doctor Instructions Always follow your doctor’s instructions.
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Post-Implant Medical Tests and Procedures Before you undergo any medical tests or procedures, you should contact your doctor to determine if the procedure will cause damage to your System. The following procedures or tests should only be performed and the following devices should only be used after talking to your doctor: facial nerve blocks (for example, infra-orbital or maxillary), orthodontic or dental procedures, and cosmetic procedures.
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Remote Controller considerably (for example, do not leave the Remote Controller in your car or under direct sunlight for long periods of time). Charging the Pulsante® Remote Controller Only use the Charger provided in the Remote Controller packaging to charge the Remote Controller. Use of non-Pulsante® charging equipment to charge the Remote Controller can damage your Remote Controller. Scuba Diving or Hyperbaric Chambers Yes, you can enjoy swimming and diving with your Microstimulator.
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• • • • • • • • • • • • • • Trismus (lockjaw) Itching Pain in the area of the implant Infection Bleeding Facial asymmetry Allergic response to implanted materials Headache Penetration of the sinus wall Increased severity/frequency of cluster headaches Post-operative nausea or emesis (vomiting) Nose bleed Ear or nasal fullness/rhinorrhea (nasal discharge) Taste alteration Possible side effects of SPG stimulation include: • Discomfort or pain during stimulation associated with paresthesia (a sensation of ti
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9. PATIENT USE INSTRUCTIONS: HOW TO OPERATE YOUR REMOTE CONTROLLER Getting Started It is important to follow your doctor’s instructions for taking any medication, including antibiotics and to report any side effects from the surgery or therapy to your doctor. Following your surgery, your doctor will work with you to treat your headaches. Your doctor will use a Remote Controller to communicate with your Microstimulator.
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Figure 5: Remote Controller Screen When Ready to Start Figure 6: Remote Controller Screen When Searching for Your Microstimulator NOTE: Therapy is only provided when the Communication Disk is held over your Microstimulator and the Remote Controller is NOT vibrating. NOTE: The Remote Controller will search for the Microstimulator for approximately one (1) minute. If the Microstimulator is not located, the Remote Controller will turn OFF and the screen will go blank.
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Figure 8: Example Headache Diary Question Screen Starting Pain? Moderate Charging the Pulsante® Remote Controller The Remote Controller Display Screen will tell you how much battery power remains. Make sure the Remote Controller is charged often. To increase the life of the Remote Controller, charge the Remote Controller daily as you would a cell phone. Only use the Charger provided in the Remote Controller packaging to charge the Remote Controller.
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Figure 11: Charger and Adapters NORTH AMERICA ADAPTER PROTECTIVE CASING EUROPEAN UNION ADAPTER SLIDE SWITCH UNITED KINGDOM ADAPTER Charger Adapters Follow these instructions to set up and use the Charger: • Remove the protective casing by pushing the Slide Switch down (Figure 12). • Connect the North American Adapter to the Charger (Figure 13). • To change Adapters, remove the existing Adapter by pushing the Slide Switch down and removing the Adapter.
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Figure 14: Orientation of the Charger’s USB Plug and the Remote Controller Figure 15: Connecting the USB Plug End Figure 16: Remote Controller Display Screen When Charging Figure 17: Remote Controller Display Screen When Fully Charged Ensure that the correct Adapter is properly inserted into the Charger prior to inserting the Charger into the power socket. Keep the Charger away from children.
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• • • • Handle the Remote Controller with care. Avoid dropping, striking, or stepping on the Remote Controller. Do not take apart or tamper with the Remote Controller. Clean the outside of the Remote Controller using an alcohol wipe (such as a Walgreens® 70% Isopropyl Alcohol Wipe) when needed. Do not clean it with bleach, nail polish remover, mineral oil, or similar substances. The Remote Controller is Not waterproof.
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10. TROUBLESHOOTING If your Remote Controller and/or Charger are not working, please contact your doctor. The serial number is provided on the back of the Remote Controller. You may need to provide the serial number to your doctor. You may also have to return the Remote Controller and/or Charger for analysis and request a replacement. If your Remote Controller does not work with your Microstimulator: Check the battery indicator on your Remote Controller and, if needed, recharge the Remote Controller.
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If the Remote Controller begins to vibrate loudly: Check the Display Screen for any alerts or notifications such as the Alert Indicator or the Depleted Battery symbol. 11. TECHNICAL DESCRIPTION AND SPECIFICATIONS USA-Federal Communications Commission (FCC) The following is communication regulation information on the Pulsante SPG microstimulator system comprises of Neurostimulator NS-100 and Remote Controller RC-300.
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Electromagnetic Compatibility The use of cables other than those specified or sold by Autonomic Technologies may result in increased emissions or decreased electrical immunity of the system. The RF transmitter within the remote controller operates at 126 kHz +/- 3kHz, with Frequency Shift Keying (FSK), and the effective radiated power of less than 5mW. NOTE: The device remains safe under its typical electromagnetic interference environment.
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MATERIALS Microstimulator Body and Lead Electrodes Bone Fixation Plate SPECIFICATION Polyurethane-silicone co-polymer (Material Contacts Human Tissue) Platinum (90%) / Iridium (10%) (Material Contacts Human Tissue) Titanium, Grade 2 (Material Contacts Human Tissue) Specifications for the Pulsante® Remote Controller: PHYSICAL CHARACTERISTICS Remote Controller Size Weight Case Material Connector Storage/Operating/Transport Temperature Range / Humidity ELECTRICAL CHARACTERISTICS Power Battery Charge Life Tot