Summary of Contents for Stim Wave Technologies PDBT-915-2K
- Page 1 EARABLE NTENNA SSEMBLY ANUAL Caution: Federal law restricts this device to sale by or on the order of a physician. (PDBT-915-2K) EARABLE NTENNA SSEMBLY EARABLE NTENNA SSEMBLY (PDBT-915-2A)
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Page 2: Explanation Of Symbols On Product Or Package
XPLANATION OF YMBOLS ON RODUCT OR ACKAGE Refer to the appropriate product for symbols that apply. Symbol English – EN Device reference identification Lot number Quantity of product included in package Consult instructions for use Do not reuse Do not resterilize Do not use if package is damaged Store in a cool, dark, dry place Caution... -
Page 3: Table Of Contents
ABLE OF ONTENTS EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE .....2 HOW TO USE THIS MANUAL ...............4 ................4 NDICATIONS FOR SAFETY INFORMATION ...............5 .................. 5 ONTRAINDICATIONS ....................6 ARNINGS ..................11 RECAUTIONS ............... 14 DVERSE VENT UMMARY PARTS OF YOUR STIMULATION SYSTEM ..........15 ............ -
Page 4: How To Use This Manual
OW TO USE THIS MANUAL This manual will help you understand how to use and care for your neurostimulator system. It also provides you with warnings and precautions you should know about. You should discuss with your clinician any questions or concerns you have after reading this manual. -
Page 5: Safety Information
AFETY NFORMATION ONTRAINDICATIONS • Poor surgical risks – Spinal cord stimulators should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. This includes patients who need anticoagulation therapy that cannot be temporarily halted to accommodate the implantation procedure. -
Page 6: Warnings
ARNINGS Electromagnetic interference (EMI) – EMI is a field of energy generated by equipment found in the home, work, medical or public environments. EMI that is very strong can interfere with System. The device includes features that provide protection from EMI. Most electrical device and magnets encountered in a normal day will not affect the operation of the System. - Page 7 • Electric arc welding or resistance welding equipment used for melting and joining metals or plastics. • Industrial electric induction furnace/heater electric furnace/heater used for melting metals and plastics. • High-voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area). •...
- Page 8 Electrocautery – If electrocautery tools are used near the Stimulator then the insulation can be damaged. The Stimulator may fail or conduct induced currents. Induced electrical currents can cause heating that results in tissue damage. When electrocautery is necessary, these precautions must be followed: •...
- Page 9 When possible, it is best to avoid RFID emitters or remove the WAA while passing near RFID emitters. Patients with an implanted device should inform the attendant who may be able to assist them in bypassing any RFID emitter. If unavoidable, the patient should walk through the RFID emitter and promptly move away from the area.
- Page 10 Laser procedures – Safety has not been established for lasers within the vicinity of the Freedom SCS System. Use of lasers may result in damage to the device or harm to the patient. Radiation therapy – Safety has not been established for high radiation sources such as cobalt 60 or gamma radiation when implanted with the Freedom SCS System.
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Page 11: Precautions
RECAUTIONS Physician training – Prescribing clinicians should be experienced in the diagnosis and treatment of chronic intractable pain and should be familiar with using the Freedom SCS System. Implanting clinicians should be experienced in spinal procedures and should review the procedures described in the Instructions for Use. - Page 12 Use the WAA as directed – Use the WAA only as explained by the clinician or as discussed in the User Manual. Using the WAA in any other manner could result in harm. Do not dismantle the WAA– Do not dismantle or tamper with the device. Tampering with the device could result in harm.
- Page 13 Interference during programming - If interference is suspected during programming of the WAA, the clinician should confirm that the Bluetooth® data transmission is operating properly. Bluetooth® data communication is confirmed by the solid blue light on (when device is paired) and a fast blinking yellow light (only when data is transmitted).
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Page 14: Adverse Event Summary
DVERSE VENT UMMARY Implantation of a spinal cord stimulation system is similar to any surgical procedure. Risks include the following: • Allergic or immune system response to implanted material • Infection • Leakage of cerebrospinal fluid • Epidural hemorrhage, hematoma, or paralysis Therapeutic use of the Freedom SCS System incurs the following risks: •... -
Page 15: Parts Of Your Stimulation System
ARTS OF YOUR TIMULATION YSTEM Freedom Stimulator – Also known as an “implant” or “receiver”. The Stimulator is a set of thin wires and a miniature receiver, covered with a protective casing. The Stimulator has small metal electrodes near the tip that are set to different electrical polarities. -
Page 16: Overview Of The User Controls
VERVIEW OF THE ONTROLS BUTTONS Action Description Increase Amplitude Button – Used to increase the stimulation strength. Holding the button down for more than 2 seconds ramps the amplitude to the highest level, 24. Power ON/OFF Button – Used to turn the WAA ON or OFF. Green LED is a default indicator and will blink to indicate power status. -
Page 17: Positioning The Waa
OSITIONING THE ARNING ▪ Do not place the WAA directly on your skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The WAA must be placed overtop a thin layer of clothing at all times. Steps: The antenna must be placed over the general region of the Stimulator- Receiver in order to transfer the optimal amount of energy. -
Page 18: Starting Stimulation
TARTING TIMULATION Notes: WAA automatically starts at lowest amplitude setting when turned on. ▪ Steps: Place the WAA Antenna directly over top of the Stimulator-Receiver. Turn on the WAA by pressing the Power ON/OFF Key until the green Power Indicator Light activates. Adjust the amplitude as directed by your clinician by using the Increase or Decrease Amplitude Key. -
Page 19: Maintenance
Situation Action Stimulation is too strong Decrease amplitude with the Decrease Stimulation Key Stimulation is not strong enough Increase amplitude with the Increase Stimulation Key You have unexpected changes in Remove the WAA stimulation Decrease amplitude Put the WAA on your body Adjust amplitude to desired level You have tried adjusting stimulation Contact your clinician... - Page 20 Common Questions Response How long will it take to It normally takes an average of three (3) recharge a “dead” or hours to recharge the battery. depleted battery? When is the battery near The yellow indicator light will begin depletion, and how will I blinking.
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Page 21: When To Call Your Clinician
HEN TO ALL YOUR LINICIAN Contact your clinician if any of the following events occur: • You have pain, redness, or swelling later than 6 weeks after the implant procedure. • The stimulation is causing you to have pain or discomfort. •... -
Page 22: Atient Dentification Ard
ATIENT DENTIFICATION A patient identification card (ID) is mailed to you after Stimwave receives your registration form. The patient ID card supplies information about you, your stimulator system, and your doctor. Your identification cad may allow you to bypass security devices. Carry this card with you at all times. If you move, change doctors, or lose your card, contact Stimwave for a replacement card. -
Page 23: Wireless Information
IRELESS NFORMATION The Freedom SCS System uses wireless technology to program the WAA and to power the Stimulator. The WAA is programmed utilizing Bluetooth® data communication protocol. Bluetooth is used only during programming sessions and only by a trained clinician. Various programs are stored in memory within the WAA, which can be selected as needed. -
Page 24: Troubleshooting
ROUBLESHOOTING NOTE: If a problem is not solved after several attempts, or if a problem is not ▪ described here, contact your clinician or Stimwave representative. This information can help you to solve problems that may arise with the WAA. It also provides information on when to call your clinician. - Page 25 Problem Causes and Actions The WAA is unresponsive: The WAA is not powered on. The indicator light does not ▪ Turn the power ON. turn on. The stimulation The WAA system has “frozen”. amplitude keys do not ▪ Turn the power OFF and wait 5 seconds respond.
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Page 26: Contact Information
ONTACT NFORMATION ANUFACTURER Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach, Florida 33064 United States Telephone: +1.800.965.5134 Fax: +1.800.965.5134 Internet: www.stimwave.com 05-00523-5 Published June 2017 UROPEAN UTHORIZED EPRESENTATIVE Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands USTRALIAN PONSOR Emergo Australia...
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