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ABLE OF

ONTENTS

EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE .....................2

HOW TO USE THIS MANUAL ...............................................................4

NDICATIONS FOR

................................................................................ 4

SAFETY INFORMATION .......................................................................5

ONTRAINDICATIONS

.................................................................................. 5

ARNINGS

............................................................................................... 6

RECAUTIONS

......................................................................................... 11

DVERSE

VENT

UMMARY

....................................................................... 14

PARTS OF YOUR STIMULATION SYSTEM ............................................ 15

VERVIEW OF THE

SER

ONTROLS

............................................................ 16

OSITIONING THE

WAA ............................................................................ 17

TARTING

TIMULATION

........................................................................... 18

ELECTING A

TIMULATION

ROGRAM

........................................................ 18

NCREASING OR

ECREASING

MPLITUDE

.................................................... 18

MAINTENANCE ................................................................................ 19

ATTERY

HARGING

................................................................................. 19

HEN TO

ALL YOUR

LINICIAN

................................................................. 21

LEANING AND CARE PRECAUTIONS

............................................................ 21

AFETY AND TECHNICAL CHECKS

................................................................. 21

WAA

DISPOSAL

....................................................................................... 21

ATIENT

DENTIFICATION

ARD

.................................................................. 22

SPECIFICATIONS ............................................................................... 22

WIRELESS INFORMATION ................................................................. 23

TROUBLESHOOTING ......................................................................... 24

CONTACT INFORMATION ................................................................. 26

Содержание PDBT-915-2A

Страница 1: ...EARABLE ANTENNA ASSEMBLY USER MANUAL Caution Federal law restricts this device to sale by or on the order of a physician WEARABLE ANTENNA ASSEMBLY KIT PDBT 915 2K WEARABLE ANTENNA ASSEMBLY PDBT 915 2A...

Страница 2: ...on 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 Un...

Страница 3: ...TIMULATION SYSTEM 15 OVERVIEW OF THE USER CONTROLS 16 POSITIONING THE WAA 17 STARTING STIMULATION 18 SELECTING A STIMULATION PROGRAM 18 INCREASING OR DECREASING AMPLITUDE 18 MAINTENANCE 19 BATTERY CHA...

Страница 4: ...1 changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Per FCC 15 19 a 3 and a 4 This device complies with p...

Страница 5: ...thermy can be transferred through the stimulator or WAA and cause tissue damage resulting in severe injury Implanted cardiac systems Patients who have implanted cardiac systems should not use the Free...

Страница 6: ...h the unexpected change in stimulation could feel uncomfortable it does not damage the device or cause a patient direct injury In rare cases as a result of the unexpected changes in stimulation patien...

Страница 7: ...devices These devices include other neurostimulation systems insulin pumps automated external defibrillators AED cochlear implants and wearable medical sensors Malfunction and or damage could occur t...

Страница 8: ...Psychotherapeutic procedures Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference e g electroconvulsive therapy transcranial mag...

Страница 9: ...o the implanted device by o Using the lowest possible X ray tube current consistent with obtaining the required image quality o Making sure that the X ray beam does not dwell over the Stimulator for m...

Страница 10: ...affect the device Diagnostic ultrasound e g carotid scan Doppler studies Diagnostic x rays or fluoroscopy Magnetoencephalography MEG Positron emission tomography PET scans Therapeutic magnets e g mag...

Страница 11: ...The WAA is a sensitive electronic device Avoid dropping the device onto hard surfaces Keep the WAA out of the reach of children and pets Storage temperatures The Freedom SCS System should be kept with...

Страница 12: ...ture 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...

Страница 13: ...low light only when data is transmitted If during the programming session the light indicator is not blinking then the clinician should do the following Terminate the current programming session and s...

Страница 14: ...magnetic interference causing a change in System performance Loss of therapeutic effect despite a functioning system Adverse events that could occur with the Freedom SCS System Stimulator migration re...

Страница 15: ...e Antenna Assembly WAA The WAA is an electronic device used to power the Stimulator The device contains a rechargeable battery with an antenna and micro USB port for charging only The WAA is worn near...

Страница 16: ...Used to decrease the stimulation strength Holding the button down for more than 2 seconds ramps the amplitude to the lowest level 1 Change Program Selection Depressing the Increase Amplitude Button a...

Страница 17: ...ust be placed overtop a thin layer of clothing at all times Steps 1 The antenna must be placed over the general region of the Stimulator Receiver in order to transfer the optimal amount of energy 2 Th...

Страница 18: ...A defaults to the last program used 2 Press and buttons at the same time to switch programs 3 The light pattern will blink to signify which program is active INCREASING OR DECREASING AMPLITUDE CAUTION...

Страница 19: ...e provided to perform charging The battery is built into the WAA and does not need to be removed Contact your clinician if you experience poor battery life You will need the USB Charger Kit to recharg...

Страница 20: ...t this from harming the battery Connect the WAA to the charger as described How long will a fully charged battery provide power Eight 8 hours on average The battery performance is affected by the amou...

Страница 21: ...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 Keep the device out of the reach of children and p...

Страница 22: ...rapy 5 to 1 500 Hz Number of Channels 2 Number of Programs selectable 3 Transmit Carrier Frequency 915 MHz Bluetooth Frequency 2 402 GHz Charger Power Source 120 240V 50 60 Hz power line Operating sto...

Страница 23: ...nd Stimulator is broken stimulation will cease The wireless link may not function in the presence of large magnetic or radio fields Bluetooth Version 4 1 Low Energy Only Bluetooth Version of WaveCrest...

Страница 24: ...suitable for your activity or posture Reduce the amplitude of the WAA Remove WAA from your body Intermittent stimulation You feel stimulation only some of the time WAA may have a poor connection with...

Страница 25: ...prevent the battery from getting too hot If the WAA seems to be heating up excessively while charging then unplug the charging cable from the WAA and let it sit in a well ventilated area for a few min...

Страница 26: ...United States Telephone 1 800 965 5134 Fax 1 800 965 5134 Internet www stimwave com 05 00523 5 Published June 2017 EUROPEAN AUTHORIZED REPRESENTATIVE Emergo Europe Prinsessegracht 20 2514 AP The Hagu...

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