Stim wave LBRD-915-2A User Manual Download Page 31

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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

Summary of Contents for LBRD-915-2A

Page 1: ...ENNA ASSEMBLY USER MANUAL Caution Federal law restricts this device to sale by or on the order of a physician WEARABLE ANTENNA ASSEMBLY PROGRAMMER KIT LBRD 915 2K WEARABLE ANTENNA ASSEMBLY PROGRAMMER...

Page 2: ...umber 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 Conditiona...

Page 3: ...RVIEW OF THE USER CONTROLS 17 POSITIONING THE WAA PROGRAMMER 18 TURNING THE WAA PROGRAMMER ON OR OFF 19 STARTING STIMULATION FOR THE STIMULATOR 19 SELECTING A STIMULATION PROGRAM 20 INCREASING OR DECR...

Page 4: ...ity to operate the equipment Per FCC 15 19 a 3 and a 4 This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful inter...

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

Page 6: ...patients have described as a jolting or shocking sensation Although the unexpected change in stimulation could feel uncomfortable it does not damage the device or cause a patient direct injury In rare...

Page 7: ...pment or animals Active Implantable or Body Worn Medical Devices Safety has not been established for patients who use the Freedom SCS System with other active implantable or body worn medical devices...

Page 8: ...ground pads should not be used After electrocautery confirm that the Stimulator is working as intended Electrostatic Discharge ESD Testing indicates the WAA can be susceptible to damage resulting from...

Page 9: ...tion near a potential RFID emitter they promptly move away from the area and remove the WAA from the body When possible it is best to avoid RFID emitters or remove the WAA while passing near RFID emit...

Page 10: ...icinity of the Freedom SCS System Use of electrolysis may result in damage to the device or harm to the patient Laser procedures Safety has not been established for lasers within the vicinity of the F...

Page 11: ...occur PRECAUTIONS 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 Im...

Page 12: ...ipment during flights Refer all questions to airline personnel Use the WAA Programmer as directed Use the WAA only as explained by the clinician or as discussed in the User Manual Using the WAA Progra...

Page 13: ...other activities can cause a perceived increase in stimulation Some patients have described this as a jolting or shocking sensation You should reduce your amplitude to the lowest setting and turn OFF...

Page 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...

Page 15: ...es of the spinal cord The Stimulator receives energy wirelessly from the external unit WAA Wearable Antenna Assembly WAA Programmer The WAA Programmer is an electronic device used to power the Stimula...

Page 16: ...r to your Stimulator 2 User Controls Controls used to turn the power on off and adjust stimulation amplitude 3 Belt An adjustable belt that holds the transmitter The transmitter should be placed in th...

Page 17: ...crease 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 Cha...

Page 18: ...ower 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: ...n 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...

Page 20: ...etermine 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 Bl...

Page 21: ...roughout 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 A...

Page 22: ...ur midsection 2 Remove the WAA Programmer from the pouch 3 Connect the USB cable to the power adapter 4 Plug the power adapter into a wall outlet 5 Connect the opposite end of USB cable to the micro U...

Page 23: ...by running the battery completely empty The device has safeguards to prevent this from harming the battery Place the WAA Programmer on the charger as described How long will a fully charged battery p...

Page 24: ...ins no user serviceable parts If repair or service is needed contact your clinician or a Stimwave representative for a replacement Refer to the contact information at the end of this manual WAA PROGRA...

Page 25: ...s 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 communi...

Page 26: ...o 60 C 0 F to 140 F 20 to 90 Operating storage atmospheric pressure 70 kPa to 150 kPa 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...

Page 27: ...e penetration depth Up to 4 inches or 10 cm Quality of Service In order for the Freedom SCS System to operate the WAA Programmer should be centered over the Stimulator within 0 8 inches or 2 cm To bet...

Page 28: ...ncryption and proprietary data protocols to reduce the likelihood of inadvertent control or malicious hacking of the System through Bluetooth Only the WaveCrest Application is able to communicate with...

Page 29: ...ctivity or posture Reduce the amplitude of the WAA Programmer Remove the WAA Programmer from your body Intermittent stimulation You feel stimulation only some of the time WAA Programmer may have a poo...

Page 30: ...cabinet or table WAA Programmer is designed to withstand a short drop on a hard surface and still operate normally Try powering ON the WAA Programmer and allow it to transmit for 10 minutes while not...

Page 31: ...33301 United States Telephone 1 800 965 5134 Fax 1 800 965 5134 Internet www stimwave com 05 0231 7 Published May 2016 EUROPEAN AUTHORIZED REPRESENTATIVE Emergo Europe Molenstraat 15 2513 BH The Hagu...

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