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Advanced Bionics Precision SCS, Handbook

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Patient System Handbook

iv

Getting Started 

........................................................................... 28

Charging Your Implant 

................................................................ 29

Help ............................................................. 33

Stimulation 

................................................................................. 33

Remote Control Display 

............................................................... 34

Accessories 

................................................................................ 35

Contacting Advanced Bionics 

..................................................... 36

Limited Warranty .......................................... 37

Implanted Pulse Generator 

.......................................................... 37

Externals 

.................................................................................... 39

Summary of Contents for Precision SCS

Page 1: ......

Page 2: ...Patient System Handbook CAUTION Investigational device Limited by Federal or United States law to investigational use 9055072 001 Rev C ...

Page 3: ...y Copyright 2003 by Advanced Bionics Corporation All Rights Reserved Any copying reproduction or translation of all or part of the contents of this document without the express written permission of Advanced Bionics Corporation is strictly forbidden by the provisions of the law of March 11th 1957 Guarantees Advanced Bionics Corporation reserves the right to modify without prior notice information ...

Page 4: ...arnings 5 Precautions 7 Adverse Effects 11 The Remote Control 12 Basic Operation 14 Stimulation On and Off 15 Stimulation Level Control 16 Selecting Areas for Stimulation Control 17 Selecting Programs for Stimulation Control 18 Options 21 Remote Control Battery Replacement 25 Charging the Implant 27 ...

Page 5: ...m Handbook iv Getting Started 28 Charging Your Implant 29 Help 33 Stimulation 33 Remote Control Display 34 Accessories 35 Contacting Advanced Bionics 36 Limited Warranty 37 Implanted Pulse Generator 37 Externals 39 ...

Page 6: ...tor surgically implanted you confirmed that paresthesia is capable of providing you with good to excellent pain relief Going forward with this therapy your health professionals will work with you to find the most comfortable level of paresthesia to cover the painful areas through adjusting the settings Although you may have pain areas that cannot be reached by spinal cord stimulation the goal is t...

Page 7: ...te Control and is periodically recharged using a separate Charging System The Remote Control the heart of the Precision system is a powerful yet easy to use tool for managing every aspect of your pain treatment from controlling the level or strength of stimulation to accessing special treatment programs and program options For your Precision system it s important to learn 1 what to be aware of for...

Page 8: ...ur Temporary Patient Identification Card be sure to keep it with you until you receive your permanent card If any item is missing please call our Customer Service department at 866 566 8913 1 Remote Control 1 IPG Charger 1 Charger Base Station 1 Transformer 1 Belt Clip Holster 1 Velcro Charging Belt 1 Charger Adhesives 52 pieces 1 Remote Control Battery 1 Carrying Case ...

Page 9: ...ransformer Next connect the transformer to the Charger Base Station and locate the Base Station on a flat surface Finally place the Charger in the Base Station with the blue power button facing up For now that s all you need to do to get started For more information on the Charging System and its use see Charging the Implant on page 27 ...

Page 10: ...rough your stimulator system causing tissue damage at the lead site and possibly severe injury or death Cardiac Pacemakers Spinal cord stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers and implantable cardiac defibrillators ICDs Be sure your physicians are aware of your spinal cord stimulator before going forward with other implantable device therapie...

Page 11: ...ls In rare instances you could experience an increase in stimulation level to the point that the sensation is uncomfortably strong or possibly jolting If this happens turn off the IPG If the IPG suddenly turns off by itself first move away from the area Next check the implant status with the Remote Control by pressing the power button and observing the screen The IPG may need to be recharged befor...

Page 12: ...ncomfortable or jolting sensation Medical Devices Therapies The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the implant particularly if used in close proximity to the device lithotripsy electrocautery external defribrillation radiation therapy ultrasonic scanning high output ultrasound Before having procedures medical therapies or diagnostics...

Page 13: ...rarily there may be some pain in the area of the implant as the incisions heal If discomfort continues beyond two weeks contact your physician If you notice excessive redness around the wound areas during this time contact your physician to check for infection and administer proper treatment In rare cases adverse tissue reaction to implanted materials can occur during this period Implant Location ...

Page 14: ...ively hot or cold conditions Do not leave the devices in your car or outdoors for extended periods of time The sensitive electronics can be damaged by temperature extremes particularly high heat If the Remote Control or the Charging System is to be stored for a period of time be careful that the storage temperature does not exceed 20 60 C 4 140 F Handling Handle the system components and accessori...

Page 15: ...l will only operate with the special 3 6 volt battery available from Advanced Bionics Remote Control Charging System Cleaning The components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue Residue from soapy detergents should be removed with a damp cloth Do not use abrasive cleansers for cleaning ...

Page 16: ...ware malfunctions loose connections electrical shorts or open circuits and lead insulation breaches can result in ineffective pain control Tissue reaction to implanted materials can occur Skin erosion at the IPG site can occur over time Possible surgical procedural risks are temporary pain at the implant site infection cerebrospinal fluid CSF leakage and although rare epidural hemorrhage seroma he...

Page 17: ... The Remote Control unit is your direct link to choices available for tailoring spinal cord stimulation to suit your comfort and convenience requirements Keep the Remote Control with you at all times in a pocket purse or in your immediate vicinity ...

Page 18: ... Activate or save new programs Change stimulation options If enabled by the clinician See Stimulation Level Control on page 16 Each button function label shown on the screen is related to the control button below it As you move through the screen the function labels for the buttons will change accordingly ...

Page 19: ...ntrol will go to sleep after 60 seconds Good communication between the implant and the Remote Control is very important This is the reason you ll often see the message Connecting while you are adjusting the stimulation This is normal because the Remote Control continually checks for the implant Note If you have trouble communicating with the implant the message No Response will appear on the Remot...

Page 20: ...n and Off The Remote Control uses a dedicated stimulation on off switch You may press the stimulation power button at any time to turn stimulation on or off You don t have to be concerned about whether or not the Remote Control is awake ...

Page 21: ...ation whether you have one area of pain control or more than one Note In some cases health professionals can give you control over more than one stimulation area Multiple area control is available only if your system has been programmed to deliver stimulation to separate areas If you do not have separate area control for example left leg vs right leg but feel that separate control might improve yo...

Page 22: ...cycle through your programmed areas Each area is given a number 1 through 4 or a name for example LeftLeg Note If you only have one area of control that area will appear each time you press SEL 1 2 When the named or numbered area that you want to adjust is displayed press T or S to change the stimulation level for that area ...

Page 23: ...essional Each saved program will have certain differences in the settings These differences allow you to vary your stimulation in many ways You may have been encouraged to try using specific programs for different circumstances postural positions or times in your daily routine Program flexibility gives you and your healthcare professional a way to continually fine tune your therapy ...

Page 24: ... choose the program you want to activate 3 Once the desired program is highlighted press T ACT activate and that program will start running after a couple of seconds Note You might not have four the maximum programs saved in your Remote Control Empty program slots will have an asterisk symbol beside the program number If you try to activate an empty program nothing will happen ...

Page 25: ...the stimulation level using the T down or S up button If you make a stimulation level adjustment and decide that you prefer it go back and select the program again then press S SAVE The program will be updated with the new level You may also save to an empty program slot if one is available ...

Page 26: ...e them you may realize that you probably won t use this special feature very often However if your Remote Control has been set up to access options follow the steps below to make changes There are three possible options One of these RESTORE is not a stimulation setting but is similar to an undo feature returning a program to settings from the clinic The other two options are stimulation settings t...

Page 27: ...old SEL 2 until you see the options screen 2 From the options screen press SEL 1 to move through the choices shown on the screen 3 When the option you want is highlighted press S GO Note If you change your mind about adjusting options press SEL 2 NEXT to return to the main screen ...

Page 28: ...er you chose to that area 3 If you want to adjust the same option for another area press SEL 1 to find the area Note The Remote Control will beep to notify you if you reach a preset limit while increasing or decreasing either the Rate or Width 4 When you ve made all of your changes for one option press SEL 2 BACK to return to the options screen 5 Press SEL 1 to work with another option as describe...

Page 29: ...ight the program you want to restore then press S GO The Remote Control will display a question for you to confirm press S RESTR You ll then see a message that the selected program is being restored When the operation is complete the remote will return automatically to the main screen ...

Page 30: ...y to use any button except the power button you will be reminded Replace Remote Battery ON OFF ONLY The battery for your Remote Control is a special 3 6 volt battery available only from Advanced Bionics Do not attempt to use a 1 5 volt AA battery in the Remote Control If you do not have an extra battery in your Patient Take Home Kit call Advanced Bionics Customer Service Department at 866 566 8913...

Page 31: ...ress down on the ridged area below the lever using your thumb to release the cover 3 Open the cover and remove the old battery 4 Replace the new battery in the slot matching the positive and negative markings 5 Close the compartment by sliding the lock lever to the right The Remote Control will connect and reload information from the implant in approximately 30 seconds ...

Page 32: ...The Remote Control will also provide battery status when your implant is low Based on your stimulation settings you may charge once a week or once a day You should be aware that if you do not charge your implant stimulation will eventually stop until you charge again Remember to schedule this important time Charging the implant is a simple process requiring little effort ...

Page 33: ...place with a flat clear surface to keep the Base Station plugged in 2 Plug the transformer into a standard AC wall outlet then plug the cord into the Base Station 3 Place the Charger in the base When charging you can opt to use either a Velcro belt or adhesive patches To get started using a Velcro belt you can cut it to your size for comfort We recommend using the adhesive patches since they maint...

Page 34: ...ge the implant It may be used but it may not be able to return your implant to a full charge so you may need to charge sooner than you normally would Green ready for full charge Yellow partial charge Off not ready for charging Charging Your Implant 1 When the indicator light is green remove the Charger from the Base Station The indicator light will go out regardless of the ready status ...

Page 35: ... the clear liner from the patch Remove the skin side beige liner Using the Velcro Belt Place the Charger in the pocket with the power button facing out 3 Press the power button The indicator light will return to the status position and the Charger will begin beeping steadily to signal that it is searching for the implant ...

Page 36: ... in the wrong place or if the Charger moves out of alignment the Charger will start beeping again Use a new adhesive patch or readjust the Velcro belt to place the Charger back to position 5 When the Charger emits a distinct double beep the implant is charged Switch off the Charger remove the adhesive patch or Velcro belt and return the Charger to the Base Station Do not confuse the end of charge ...

Page 37: ...gnment indicator is a steady continuous signal The implant battery will eventually need replacement Over time typically over years you may start to charge more frequently As long as it is convenient you can use the system When you are ready for a replacement talk with your healthcare professional ...

Page 38: ...ion from the main screen or area screens 3 Charge the implant When the charge is complete try turning the stimulation on 4 Call our Customer Service Department at 866 566 8913 if the above steps do not solve the problem Stimulation Increases or Decreases on Its Own 1 Stimulation can change depending on body position lying down standing or bending 2 Always keep the Remote Control with you so that y...

Page 39: ...ion If you cannot turn the stimulator back on with your Remote Control you may need to charge the implant 3 When the implant battery needs to be recharged it will stop stimulating Recharge and turn stimulation back on If the implant regularly stops stimulating before you charge you can charge more often Remote Control Display Remote Battery Low on the Display The battery in your Remote Control nee...

Page 40: ...hen the Remote Control displays Action Unsuccessful press OK and try the action again If pressing OK does not clear the message call your physician s office Accessories AA Batteries Do not use AA Batteries The Remote Control requires the special 3 6 volt battery from Advanced Bionics because a standard AA battery is not powerful enough The two batteries may look the same but they are very differen...

Page 41: ... or need to contact Advanced Bionics for any reason you may do so in any of the following ways Customer Service Phone 866 566 8913 Customer Service Fax 661 362 1503 Address Advanced Bionics Corporation Pain Management Division Mann Biomedical Park 25129 Rye Canyon Loop Valencia CA 91355 ...

Page 42: ...n 1 year from the date of surgery is covered under this Limited Warranty The liability of Advanced Bionics under this warranty shall be limited to a replacement with a functionally equivalent IPG or b full credit equal to the original purchase price to be applied towards the purchase of a new IPG Product claims under Advanced Bionics Limited Warranty are subject to the following conditions and lim...

Page 43: ... without prior approval This warranty does not include the leads extensions or surgical accessories used with the Preci sion IPG 5 The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics For a replacement IPG the warranty will run only to the end of the warranty period for the original IPG that was replaced This warranty is in lieu of any other w...

Page 44: ...t or b full credit equal to the original purchase price to be applied towards the purchase of a replacement device Product claims under Advanced Bionics Limited Warranty are subject to the following conditions and limitations 1 The product registration card must be completed and returned to Advanced Bionics within 30 days of surgery or receipt of product in order to obtain warranty rights 2 The co...

Page 45: ...Advanced Bionics For a replacement component the warranty will run only to the end of the warranty period for the original component that was replaced This warranty is in lieu of any other warranty expressed or implied including any warranty of merchantability or fitness for intended use Except as expressly provided by this Limited Warranty Advanced Bionics shall not be responsible or liable for a...

Page 46: ...88 818 362 5069 Fax 800 678 3575 TTY www advancedbionics com Email info advancedbionics com PAIN MANAGEMENT DIVISION Advanced Bionics Corporation Mann Biomedical Park 25129 Rye Canyon Loop Valencia CA 91355 661 362 1400 661 1500 Fax JUN03 080620 P 2003 Advanced Bionics Corp All rights reserved 9055072 Rev C IMAGINE the Possibilities ...

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