Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Remote Control Insert

Boston Scientific Neuromodulation Corporation Precision SCS System Remote Control II Remote Control Insert

Remote control package insert

Remote Control Copyright 2004, Advanced Bionics® Corporation. All Rights ReservedPart No. MP9055212 Rev.A.PrecisionTM Remote ControlModel SC-5210The Advanced Bionics® Remote Control is a hand-held programmer for controlling the Precision™ implantable pulse generator (IPG) for the treatment of chronic intractable pain. Following set-up of the Remote Control by the clinician, the device may allow patient management of:• stimulation on/off functions• stimulation delivery areas• individualized stimulation therapy programs• amplitude and other (optional) parameters For complete use instructions, refer to the Precision Patient System Handbook. CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician.CAUTION:• Do not expose the Remote Control to extreme temperatures. Do not leave it in a vehicle or out-of-doors.• Handle the Remote Control carefully. Although it has been durability-tested to ensure quality manufacturing and performance, dropping it on hard surfaces or in water, or other destruc-tive handling, can permanently damage the Remote Control. • Avoid all sources of water that can come into contact with the Remote Control.• Do not dispose of the Remote Control in fire. • Dispose of used batteries in accordance with any local regulations.• If the Remote Control is to be stored, maintain the storage temperature at between 41 – 104 ºF (5 – 40 ºC).Battery InformationThe Remote Control uses three AAA batteries. The device will warn you when its batteries are low and when the implant needs charging. Pay close attention to all battery messages.NOTE: Following a battery replacement, the Remote Control will need to re-connect with the stimulator. This will take about 30 seconds, and the remote must be within communication range (two feet) of the stimulator during this period.Battery Replacement:On the rear of the remote, push in slightly and slide the battery compartment cover down.Remove the old batteries.Place the new batteries in the slots by matching the positive (+) and negative (-) battery ends with the + / - markings in the compartment.Align the cover on the case and slide the cover into position until it snaps closed. General InstructionsNOTE: When it has not been used for approxi- mately one minute, the Remote Control sets itself in a sleep/idle mode and the display screen is blank. At this time, when you press any button except the E button the remote will display the “Keys Locked” message shown following. Press D to reactivate the Remote Control.1. To turn stimulation off, press the E button.2. To increase or decrease the stimulation level of all programmed therapy areas, press the either  or .3. To change the stimulation level of just one area: a) From the Level screen, press Cas many times as necessary to find the desired area by name or number. b) Press the  or  to make the change.4. To activate a stimulation program:a) Press D from the Level screen.b) From the Program screen press Das many Program ButtonArea ButtonStimulation On/Off ButtonUp/ActivateDown/SavePKeys LockedPress ToUnlockDRAFT
Remote Control Model SC 5210Copyright 2004, Advanced Bionics® Corporation. All Rights Reserved.Part No. MP9055212 Rev. Atimes as necessary to highlight the desired pro-gram.c) Press  to activate the selected program.Once the program is running, you may change the stimulation level by pressing  or .To save the new level in a program, return to the Program screen, select the intended program number, and press .Rate (If provided by physician)1. Press and hold C from the Level screen to access the Rate Area 1 screen.2. Press C (normal press) as necessary to cycle to the area you want to adjust, then press  or  to increase or decrease the Rate. Pulse Width (If provided by physician)1. From the Level screen, press and hold C to access the Rate Area 1 screen.2. From any Rate screen, press and hold Cagain to access the Width Area 1 screen. 3. Press C(normal press) as necessary to cycle to the desired area. 4. Press or  to increase or decrease Pulse Width.To save a Rate or Pulse Width change--1. Press D from the level screen. 2. From the Program screen press Das necessary to cycle to the active program.3. With the program highlighted, press  to save changes. Restore1. Press and hold D to access the Restore screen.2. Press D again as necessary to highlight the pro-gram you want to restore, then press .3. Respond to the confirmation screen to complete the operation.MaintenanceThe Remote Control may be cleaned with a cloth lightly dampened with water or a mild household cleaner. Do not use abrasive cleansers.Customer ServiceIf you have any questions concerning the use of the Precision Remote Control, please contact Advanced Bionics’ Customer Service Department:• Phone: (866) 360-4747• Fax: (661) 362-1503• Address: Advanced Bionics® Corporation Pain Management Division 25129 Rye Canyon Loop Valencia, CA 91355Limited Warranty Advanced Bionics® warrants to the patient that the Remote Control device, Model SC-5210, is free from defects in workmanship and materials for a period of one (1) year from the date of purchase of a new Precision™ Patient Kit.A Remote Control device that fails to function within normal tolerances within one (1) year from the date of surgery or purchase is covered under this Limited Warranty. The liability of Advanced Bionics® under this warranty shall be limited to: (a) replacement with a functionally equivalent component; 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 com-pleted and returned to Advanced Bionics® within 30 days of surgery or receipt of product in order to obtain warranty rights.2. The component must be returned to Advanced Bionics® (or authorized agent) within 30 days of malfunction or discovery of defect.3. The component failure must be confirmed by Advanced Bionics®. This warranty specifically excludes defects or malfunctions caused by: (a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”; (b) accident, misuse, abuse, negligence, or the customer’s failure to operate the system and its components in accordance with manufacturer’s instructions; (c) unautho-rized attempts to repair, maintain, or modify the equipment by the customer or any unauthorized third party; or (d) attachment of any equipment not supplied by Advanced Bionics® without prior approval.4. The decision as to product replacement or credit shall be made solely at the discretion of Advanced Bionics®. For a replacement compo-nent, 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 any direct, consequential or incidental damages caused by device malfunction, failure or defect, whether the claim is based on warranty, contract, tort or otherwise.

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