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English 

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W

IRELESS 

I

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 
of WAA Programmer 

915 megahertz (MHz) 

Bandwidth of WAA 
Programmer 

149 kilohertz (kHz) 

WAA Programmer Tissue 
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  better  ensure  proper 
function,  the  WAA  Programmer  should  be 
worn  in  the  same  position  as  when  it  was 
originally  fitted.  When  the  wireless  link 
between  the  WAA  Programmer  and 

Stimulator  is  broken,  stimulation  will  cease.  
The  wireless  link  may  not  function  in  the 
presence of large magnetic or radio fields. 

Bluetooth® Version- WAA 
Programmer 

4.1 (Low Energy Only) 

Bluetooth® Version of 
WaveCrest Application 

4.0 

Frequency of Bluetooth® 

2.4 gigahertz (GHz) 

Bandwidth of Bluetooth® 

900 kHz 

Power of Bluetooth® 

2.5 milliwatt (mW) 

Bluetooth® Operating 

Distance 

4 to 5 meters 

Wireless Link 
Performance 

Wireless link active less than 10% of the time 
when  the  WAA  Programmer  is  1  inch  or 
closer to the implant. 

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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