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Summary of Contents for Stim wave LBRD-915-2K
- Page 1 EARABLE NTENNA SSEMBLY SER ANUAL Caution: Federal law restricts this device to sale by or on the order of a physician. EARABLE NTENNA SSEMBLY ROGRAMMER (LBRD-915-2K) EARABLE NTENNA SSEMBLY ROGRAMMER (LBRD-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 Warning MR Conditional MR Unsafe Use by Manufacturing date Manufacturer Device length Sterilization: ethylene-oxide gas European Authorized Representative Australian Sponsor Temperature limits Page | 2 English... -
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 .......... 1 5 ............. 16 VERVIEW OF THE ROGRAMMER ............17 VERVIEW OF THE SER ONTROLS ............18 OSITIONING THE ROGRAMMER “ON” “OFF” ........19 URNING THE ROGRAMMER OR... -
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. Please refer to the Freedom Spinal Cord Stimulator (SCS) System Product Safety Guide for EMC related safety information. -
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. Pregnancy – Safety and effectiveness of the Freedom SCS System for use •... -
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. However, strong sources of EMI could result in the following: Serious patient injury resulting from heating of the implanted device • and damage to surrounding tissue. - Page 7 High-power amateur transmitters/antennas or citizen band (CB) radio • or Ham radio used for private recreation, communication, and wireless experimentation. Electric arc welding or resistance welding equipment used for melting • and joining metals or plastics. Industrial electric induction furnace/heater or electric arc • 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). Microwave transmitters identified by fenced areas, restricted access • signs, and caution signs (safe if outside the fenced area). Television and radio towers identified by fenced areas, restricted •...
- Page 8 Radiofrequency (RF) ablation – Safety has not been established for radiofrequency (RF) ablation in patients with a Stimulator. RF ablation may cause induced electrical currents that result in heating and tissue damage. Do not use RF ablation anywhere near the Stimulator. If RF ablation is used, ensure that ablation is not performed over or near the Stimulator. 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.
- Page 9 Psychotherapeutic procedures – Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) in patients who have spinal cord stimulators. Induced electrical currents can cause heating that may result in tissue damage. Radiofrequency Identification (RFID) Emitters - Theft detectors, electronic article surveillance (EAS) systems, and radiofrequency identification systems – Tests have been performed with an array of simulated RFID emitter systems, and have demonstrated that the Freedom SCS System (implanted device and...
- Page 10 After CT scanning directly over the implanted device: Place the WAA Programmer on body and turn on stimulation. • Check for proper stimulation, and that indicator lights are operating as • expected. Shut off the WAA Programmer if it is suspected that the device is not • functioning properly. Bone growth stimulators – Safety has not been established for bone growth stimulators within the vicinity of the Freedom SCS System. Use of a bone growth stimulator may result in damage to the device or harm to the patient. Dental drills and ultrasonic probes – Safety has not been established for dental drills or ultrasonic probes within the vicinity of the Freedom SCS System. Use of dental drills or ultrasonic probes may result in damage to the device or harm to the patient. Electrolysis – Safety has not been established for electrolysis within the vicinity of the Freedom SCS System. Use of electrolysis may result in damage to the device or harm to the patient.
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Page 11: Precautions
Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist • wraps, elbow wraps) – Keep the magnet away from the stimulator site. Magnetic fields will generally not affect the Stimulator. WAA Programmer Skin Contact – Do not place the WAA Programmer directly on the skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The WAA Programmer must be placed overtop a thin layer of clothing at all times. - Page 12 Clean the WAA Programmer – Clean the outside of the WAA Programmer with a damp cloth when needed to prevent dust and grime. Mild household cleaners will not damage the device or labels. Handle the WAA Programmer with care – The WAA Programmer is a sensitive electronic device. Avoid dropping the device onto hard surfaces. Keep the WAA Programmer out of the reach of children and pets. Medical tests and procedures – Before undergoing medical tests or procedures, contact the clinician to determine if the procedure will cause damage to the patient or to the System. Physician instructions – Always follow the programs and therapy instructions established by the clinician. Failure to do so may cause the therapy to be less effective in providing pain relief.
- Page 13 your stimulator to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, and additional medical procedures. Scuba diving or hyperbaric chambers – Do not dive below 13 meters (45 feet) of water or enter hyperbaric chambers above 1.5 atmospheres absolute (ATA). These conditions can damage the device. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with the clinician. Skydiving, skiing, or hiking in the mountains – High altitude should not affect the System. However, take care to not put undue stress on the Stimulator. During skydiving, the sudden jerking that occurs when the parachute opens can dislodge or fracture the Stimulator. This can result in a loss of stimulation, intermittent stimulation, and additional medical procedures.
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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: Undesired change in stimulation, including uncomfortable chest wall • stimulation Stimulator migration, erosion through the skin, or fracture causing a • loss of therapeutic effect Electromagnetic interference causing a change in System performance •... -
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 similar to the poles on a battery. An electrical field of energy is created when power is applied to the electrodes. -
Page 16: Overview Of The Waa Programmer
VERVIEW OF THE ROGRAMMER Transmitter – Used to transmit power to your Stimulator. User Controls – Controls used to turn the power on/off and adjust stimulation amplitude. Belt – An adjustable belt that holds the transmitter. The transmitter should be placed in the belt as illustrated above. Make sure the Back Side is facing your body when worn. Page | 16 English... -
Page 17: Overview Of The User Controls
VERVIEW OF THE SER ONTROLS Button Cover, Buttons and LEDs BUTTONS Key Action Description 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. Increase Amplitude Button – Used to increase the stimulation strength. Decrease Amplitude Button – Used to decrease the stimulation strength. Change Program Selection – Depressing the Increase Amplitude Button and the Decrease Amplitude Button at the same time will alternate the programmed setting to either A, B, or C. LEDS Action Description Pattern and Color Description of Pattern Solid Blue Charging (Correct Alignment) None OFF, Not Charging (Misalignment) -
Page 18: Positioning The Waa Programmer
OSITIONING THE ROGRAMMER ARNING Do not place the WAA Programmer directly on your skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The WAA Programmer must be placed overtop a thin layer of clothing at all times. The WAA Programmer must be placed over the general region of the stimulator in order to transfer the optimal amount of power to the device. Refer to the following illustrations for the best location to wear the WAA Programmer. Work with your clinician to find the optimal location for the most effective therapeutic relief. -
Page 19: Turning The Waa Programmer "On" Or "Off
This figure illustrates the optimal This figure illustrates the optimal position of the WAA Programmer over position of the WAA Programmer two vertically spaced Stimulators. over one Stimulator. “ON” “OFF” URNING THE ROGRAMMER AUTION Do not place the WAA Programmer directly on your skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The WAA Programmer must be placed overtop a thin layer of clothing at all times. Notes: WAA Programmer automatically starts at lowest amplitude setting § when turned on. Steps: Press and hold the Power ON/OFF Key until the green Power Indicator Light activates. TARTING TIMULATION FOR THE TIMULATOR... -
Page 20: Selecting A Stimulation Program
ELECTING A TIMULATION ROGRAM The WAA Programmer device has three program options that your doctor may set. Your doctor may set each program to stimulate a different part of your body. Talk with your doctor to determine when and how to use the programs. Use the green indicator light in order to identify which program is currently active on the device. Program A = One Blink • Program B = Two Blinks • Program C = Three Blinks • Steps: Turn on the WAA Programmer. -
Page 21: Increasing Or Decreasing Amplitude
NCREASING OR ECREASING MPLITUDE AUTION Turn the power off or decrease the amplitude before changing the position of the WAA Programmer. Do this to prevent possible uncomfortable or unexpected stimulation. Notes: The WAA Programmer must be turned on to increase or decrease the § amplitude. The WAA Programmer does not need to be placed over the Stimulator § to change amplitude. Steps: Press the “Up” arrow key to increase the amplitude. Press the “Down” arrow key to decrease the amplitude. To receive the most effective therapy you will need to adjust your stimulation throughout the day. Your clinician will provide guidelines about when you may want to adjust your stimulation. The following table provides general guidelines on how to adjust your stimulation. 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 Programmer Decrease amplitude stimulation Put the WAA Programmer on... -
Page 22: Maintenance
AINTENANCE ATTERY HARGING Notes: The battery is built into the WAA Programmer and does not need to be § removed. Contact your clinician if you experience poor battery life. You will need the Charger Kit to recharge the internal battery. § Steps: Remove the WAA Programmer from your midsection. Remove the WAA Programmer from the pouch. Connect the USB cable to the power adapter. Plug the power adapter into a wall outlet. Connect the opposite end of USB cable to the micro-USB port on the side of the WAA Programmer. Charging Indicator Light will blink on while the battery is charging. Allow the battery to charge for at least four hours. Charging Indicator Light will stay solid when the battery is fully charged. WAA Programmer is now ready to be used again. Page | 22 English... - Page 23 Common Questions Response How long will it take to It normally takes an average of four (4) recharge a “dead” or depleted hours to recharge the battery. battery? When is the battery near The yellow indicator light will begin depletion, and how will I blinking. Eventually the WAA know? Programmer will turn off and not respond to user controls. You should place the WAA Programmer on the charger pad as illustrated above. What happens if I deplete the You cannot damage...
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Page 24: Cleaning And Care Precautions
LEANING AND CARE PRECAUTIONS Notes: Clean the outside of the device with a damp cloth when necessary. § Mild household cleaners will not damage the device or labels. The device is not waterproof. Do not allow moisture to get inside the § device. Keep the device out of the reach of children and pets. § Use the device only as explained to you by your clinician or as § discussed in this manual. Handle the device with care. Do not drop, strike, or step on the device. § Do not dismantle or tamper with the device. § AFETY AND TECHNICAL CHECKS Periodic safety checks or maintenance of the WAA Programmer are not required. The WAA Programmer contains no user-serviceable parts. If repair or... -
Page 25: 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. • The system is not working properly. • You cannot adjust stimulation using the user controls. • You cannot place the WAA Programmer in the optimal position to • communicate with the stimulator. If you lose your WAA Programmer device. • Your clinician will schedule follow-up visits to make sure your device is working properly and that the stimulation is managing your pain. -
Page 26: Specifications
PECIFICATIONS Item Specification Amplitude 0 to 12.8 mA per electrode pair Pulse Width 50 to 500 µs Frequency (of therapy) 5 to 1,500 Hz Number of Channels Number of Programs (selectable) Transmit Carrier Frequency 915 MHz Bluetooth Frequency 2.402 GHz Charging Pad Power Source 120-240V 50-60 Hz power line Operating/storage temperature, -18º C to 60º C (0º F to 140º F) relative humidity 20% to 90% Operating/storage atmospheric 70 kPa to 150 kPa pressure (20.7 in Hg to 44.3 in Hg) Size (approximate) 10 cm x 10 cm x 2 cm (3.9 in x 3.9 in x 0.6 in) Weight (approximate) 0.5 kg (1 lb.) WAA Programmer Material (Do not Silicone and Aluminum place directly on skin, to be worn over a thin layer of clothing at all times) Parameter Min Typical Max Units Supply Voltage 120 ---... -
Page 27: Wireless Information
IRELESS NFORMATION The Freedom SCS System uses wireless technology to program the WAA Programmer and to power the stimulator. The WAA Programmer is programmed utilizing a 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 Programmer, which can be selected as needed. The WAA Programmer communicates with the Stimulator using a pulsed radio frequency signal centered at a frequency of 915 MHz. Wireless Specifications Transmission Frequency 915 megahertz (MHz) of WAA Programmer... - Page 28 Wireless Specifications Wireless Security Stimulator will only operate if it is within a very short distance of the WAA Programmer and such communication is disabled when Bluetooth® is enabled. The WAA Programmer uses encryption and proprietary data protocols to reduce the likelihood of inadvertent control or malicious “hacking” of the System through Bluetooth®. Only the WaveCrest Application able...
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Page 29: 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 Programmer. It also provides information on when to call your clinician. See the following table for a list of common problems and actions to remedy the issue. Problem Causes and Actions Uncomfortable stimulation: Selected parameter settings are not You are too uncomfortable suitable for your activity or posture. with the current stimulation § Reduce the amplitude of the WAA to think about how to Programmer. - Page 30 Problem Causes and Actions The WAA Programmer is The WAA Programmer is not powered on. unresponsive: The indicator Turn the power ON. § light does not turn on. The The WAA Programmer system has “frozen”. stimulation amplitude keys § Turn the power OFF and wait 5 seconds do not respond. before turning the power back ON. The battery is not charged. § Recharge the battery by placing the WAA Programmer on the charger. Dropped WAA Programmer: WAA Programmer is designed to withstand Your WAA Programmer falls a short drop on a hard surface and still off a cabinet or table. operate normally. Try powering ON the WAA Programmer and allow it to transmit for 10 minutes while not worn on the body.
- Page 31 ONTACT NFORMATION ANUFACTURER Stimwave Technologies Incorporated 901 East Las Olas Boulevard, Suite 201 Fort Lauderdale, FL 33301 United States Telephone: +1.800.965.5134 Fax: +1.800.965.5134 Internet: www.stimwave.com 05-0231-7 Published May 2016 UROPEAN UTHORIZED EPRESENTATIVE Emergo Europe Molenstraat 15 2513 BH, The Hague Netherlands USTRALIAN PONSOR Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia...
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