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Table of Contents
Summary of Contents for Neuros Altius System
- Page 1 Patient Controller and ® Battery Charger Manual Caution: Federal (US) law restricts this device to sale by or on the order of a physician LB-0199 Rev X7 VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document...
- Page 2 The information provided in this document may change without prior notice. This document and its contents are proprietary to Neuros Medical. No part of this manual may be reproduced, distributed, or transmitted in any form or by any method, including electronic and mechanical means, without prior written express consent from Neuros Medical Please read the complete documentation provided before you use the device.
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Page 3: Table Of Contents
5.3.1. General Medications ......................10 5.3.2. The Importance of Your Patient ID Card ................. 11 5.4. Using Your Altius System - Patient Controller ................12 Using Your Patient Controller ....................12 6.1. Communicating with the Altius IPG ..................12 6.2. - Page 4 For information that supports the clinical use of the Altius system, refer to the clinical summaries manual. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION...
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Page 5: Explanation Of Symbols
Refer to Instructions for Use Caution Magnetic Resonance (MR) unsafe Do Not Use if Package is Damaged Temperature Limitations for Transport Prescription only Medical Device Humidity Atmospheric Pressure Keep Dry VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 6: Introduction
Introduction This manual is written for people who are considering or have received the Neuros Altius high frequency nerve block system. The Altius system is designed to help people living with lower limb loss who experience chronic post-amputation pain. This manual is designed to help you understand the operation of the Altius system components intended for patient use, the Patient Controller and Battery Charger. -
Page 7: Warnings
Warnings Warnings are statements about the safety of your device. You should take warnings very seriously. If you do not follow these warnings, it is possible you could be hurt, and or the Altius system could be damaged. Magnetic resonance imaging (MRI) Safety Information. -
Page 8: Caution And Warnings Associated With Battery Charger And Patient Controller Operation
Caution and Warnings Associated With Battery Charger and 3.2. Patient Controller Operation The Altius System IPG may not properly detect a Dose on signal and fail to deliver • therapy due to a software or hardware problem, necessitating replacement. The Altius System IPG may not properly detect a Dose off signal and fail to turn •... - Page 9 If for any reason, you need stop the therapy, you may press the off button and then hold it over your IPG. The Altius system Patient Controller, or Altius Controller is powered by two replaceable AA batteries. See Section 6 of this manual for details on the proper operation of the Patient Controller.
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Page 10: Altius Battery Charger Overview
It has been implanted with a specific orientation to the skin to ensure proper communication with your Battery Charger, Patient Controller, and the Programmer system which is used by your doctor to set and monitor the Altius System. Effect on Your Activities 5.2. -
Page 11: The Importance Of Your Patient Id Card
In addition, the information they provide to Neuros Medical allows the company to register you as a recipient of a device it manufactured so that your doctor may be properly and completely notified in the event a product advisory is issued. -
Page 12: Using Your Altius System - Patient Controller
DCO NUMBER: 24-0010 RELEASE DATE: Page 12 of 28 Using Your Altius System - Patient Controller Using Your Patient Controller 6.1. The Altius Patient Controller has three buttons and several light indicators. Each Button on the patient controller initiates a function as described in detail on the following pages of this section. -
Page 13: About Your Altius Ipg Battery
You may press at any time to turn treatment off. After pressing the button, the patient controller “Off/Lock Out” indicator briefly lights up confirming the off status VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 14: Starting A Treatment Session
“locked out” and a new treatment session cannot be started at this time. Note: The treatment session can be turned off at any time by pressing the off button. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 15: Lock Out
Three quick beeps. The controller could not establish communication with the generator and has stopped trying. You will only hear three quick beeps after the conclusion of the slow repeated beeps VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 16: Understanding Battery Status
Understanding Battery Status 6.8. About the Patient Controller Batteries lights As a user of the Altius System for amputation pain, it’s essential that you understand the importance of battery power. The replaceable batteries in your patient controller and the rechargeable battery in your generator work together to provide you with dependable treatment. -
Page 17: Using Your Altius System - Battery Charger
5. Align the battery compartment cover on the case starting at the bottom of the patient controller. 6. Slide up the battery compartment lock. Using Your Altius System - Battery Charger Battery Charger Description 7.1. The charging system for your Altius generator consists of the charger unit, a charging paddle (coil), and an AC Adapter power supply. -
Page 18: Importance Of Charging Your Altius Ipg
Note: Consult local regulations if using the Charger outside of the country where it was purchased. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 19: Altius Battery Charger Features
1. Plug the AC Adapter power supply into a standard AC wall outlet Warning: Only use the AC Adapter Power Supply provided with the Altius Battery Charger to charge the Battery in the Charger. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 20: Charging Your Altius Generator
Note: Inspect the Battery Charger for any damage before each use. Contact your physician if a replacement Battery Charger is needed. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... - Page 21 6. Once the Charging Coil has established a link with the Altius IPG, the charger will begin the charging process. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document...
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Page 22: Audible Signals From The Altius Battery Charger
Three Beeps. Charger battery level is too low to continue to charge the generator and charging has stopped. You will need to charge the charger before you can start recharging the generator. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 23: Help Section
Caution: If you experience a full session, but do not feel the therapy for any part of it you may need to visit your doctor. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 24: Help With Your Patient Controller
Please contact your physician. Charger not charging. Make sure charger is unplugged from power supply as shown in the picture below. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 25: Contact Physician Indicator
Warning: Before and After cleaning the Battery Charger and AC Adapter Power Supply, ensure that it is disconnected from the Charger’s AC adapter, and the AC Adapter is unplugged from the AC mains. VERIFY THE DOCUMENT PRINTED IS THE MOST CURRENT REVISION Neuros Medical Inc. Confidential Document... -
Page 26: Altius Patient Controller & Battery Charger Maintenance
5 years. Warranty: If you experience an issue with your Altius Patient Controller or Battery Charger within 3 years from date of issue, contact your medical provider or Neuros Medical for a replacement. Power Ratings 10.1. -
Page 27: Altius Patient Controller & Battery Charger Disposal
10 years. Your specific situation and settings may result in shorter or longer battery life. All Neuros Altius generators eventually require surgical replacement as a result of battery depletion. When the battery is depleted, communication with the generator or continued treatment will not be possible. -
Page 28: Appendix I: Replaceable Parts & Cables
Appendix I: Replaceable Parts & Cables The Altius System is fully replaceable, there are no User serviceable parts. For replacement of any part of the Altius System please contact your Neuros Medical Representative. WARNING: Use of accessories, and cables other than those specified or provided by Neuros Medical could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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