SAGE Clinician Guide June 2011

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SAGE Clinician Guide

FOR THE USA Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

LB110415 Issue 5 June 2011

Restorative Therapies Inc 907 South Lakewood Ave Baltimore, MD 21224 USA Telephone: 1-800-609-9166 Fax: 1-410-878-2466 www.restorative-therapies.com Restorative Therapies Inc Lane Cove, NSW 2066 Australia Telephone: 02 8006 0939 Fax: 02 8324 6422 www.restorative-therapies.com Copyright 2005-2011 Restorative Therapies Inc

All rights reserved. No part of this document covered by the copyright herein may be reproduced or copied by any means or in any form without the written consent of Restorative Therapies Inc. Any software furnished under the license may be used or copied only in accordance with the terms set forth in the license agreement contract. Restorative Therapies Inc reserves the right to amend, modify, or revise all or part of this document without notice and shall not be responsible for any loss, cost, or damage, including but not limited to consequential damage, caused by the reliance of the information contained herein. Restorative Therapies Inc reserves the right to make changes in the product design without reservation and without notification to its patients. All other products and company names herein may be trademarks of their respective owners.

Contents Introduction ... 4   About this Guide ... 4   RTI Technical Support ... 4   What You Need to Know Before You Start ... 4   Terms used in this guide ... 5  

Login and set your RTILink preferences ... 7   Creating a New Patient Record on RTILink ... 9   Clinician login on the Sage controller... 11   System Settings ... 14   Real time stimulation adjustment ... 16  

Configuring the system ... 17   Stimulator settings ... 18   Stimulation ... 20   Adding a channel ... 24   Applying a channel change to all muscle groups ... 26   Restoring default values... 26   Patient profile ... 27   Spasm ... 27   Stimulation Response ... 28   Autonomic dysreflexia ... 28   Hemiplegia ... 28   Progression ... 29   Therapy settings – RT200/RT300 ... 30   Therapy settings – RT600 ... 34   Footplate settings – RT600 ... 38   Therapy Intervals ... 40   Pulse-oximeter leg alarm settings ... 42   Controller settings ... 44  

Linking and removing RT50 stimulators... 46   Fitting a stimulator ... 47   Removing a stimulator or Flight Mode ... 48   Pulse-Oximeter setup ... 50  

Symbols ... 52   Technical Specifications ... 53  

Introduction About this Guide This guide is a clinician’s supplement to the SAGE User Guide and the User Guide for the FES equipment that you are using. Familiarity with the applicable User Guides is assumed.

RTI Technical Support Restorative Therapies Inc (RTI) offers a technical support service to provide troubleshooting help when: •

you have read this guide but are experiencing difficulties with the SAGE system

•

the system is due for a maintenance service

•

you need to order replacement parts

Contact RTI Technical Support: •

submit a help request ticket at www.restorative-therapies.com/supportcenter

•

In the USA or Canada by calling 1 800 609-9166 and selecting option 2

•

In Australia by calling 02 8006-0939

What You Need to Know Before You Start Before you start using the SAGE System with a patient: •

read the User Guide for the equipment that you will be utilizing – in particular, check the Indications for Use, Contraindications, Cautions, Warnings and Safety Measures sections of the guide • • •

•

RT200 User Guide RT300 User Guide RT600 User Guide

explain to your patient how the Cautions, Warnings and Safety Measures detailed in the User Guide relate to them.

SAGE generates currents sufficient to cause electrocution if used improperly.

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Terms used in this guide Term

What it Means

Arm

The upper extremity limb from the shoulder to the wrist. Upper arm – from the shoulder to the elbow. Lower arm / forearm – from the elbow to the wrist.

BlueTooth

A wireless, automatic means by which electronic devices connect to each other. BlueTooth devices communicate with each other on a standard band or range of radio frequency called the ISM (industrial, scientific and medical) devices band.

Calf or leg

The lower extremity limb segment between the knee and ankle.

controller

A computerized panel used to control the SAGE system.

FES

Functional Electrical Stimulation Important information or help.

RTI

Restorative Therapies, Inc

RT200

Restorative Therapies’ FES elliptical system

RT300

Restorative Therapies’ FES cycle system

RT600

Restorative Therapies’ FES step and stand system

Surface electrode

An electrode (adhesive pad) that is attached to the skin to stimulate a group of muscles. Each surface electrode connects to the system via the stimulation cable.

Thigh

The limb segment between the hip and knee.

Torso

The part of the body from the shoulders to the waist.

Type BF Applied Part

This term is used in the “IEC 60601-1” electrical safety standard. It applies to the parts of a medical device that must physically touch a person to carry out the device’s intended function. Applied Parts are Type B, or Type BF, or Type CF depending on the nature of the device and the type of contact. Each type has different requirements for protecting people against electrical shock.

Table 1: Terms used in this guide

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This guide is divided into the following sections:

Login and set your RTILink preferences (see page 7) www.RTILink.com will store some preferences for you. This will change, for example, the default way in which patient therapies are displayed for you.

Creating a new patient record on RTILink (see page 9) How to create a new patient on www.RTILink.com

Clinician login and system settings (see page 9) System settings are parameters, which change the way the SAGE operates for all patients. You must enter the clinician login code on the SAGE controller before you can alter system settings or patient therapy parameters. This section includes details on how to link RT50 stimulators to your SAGE system.

System configuration (see page 17) The SAGE configuration functions are contained on a series of pages which become accessible after the clinician logs onto the SAGE controller by entering the clinician password on the login page. These configuration pages allow full configuration of the therapy provided by SAGE.

RT50 wireless stimulators (see page 46) Setting up the optional RT50 wireless stimulators.

Pulse-oximeter (see page 50) Setting up the optional pulse-oximeter.

Note about Research parameters: Some parameters are only accessible by entering a researcher password. They are not required for normal clinical use. The table rows in this document that describe these research parameters are shown shaded grey.

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Login and set your RTILink preferences An RTILink administrator at your clinic will set up your RTILink account for you. Once your RTILink account has been established, you will be able to log on to www.RTILink.com using your login ID and a password.

Click here if you forget your password. It will be emailed to you. Enter your user name here – usually first initial & last name

Enter your password here

At any time you can see and edit your RTILink preference by selecting the Preferences link in the top right of the screen. Please make sure that your email address is always correct otherwise RTILink will bot be able to send you reports or assist with a forgotten password.

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Clinician name Email Subscribe to progress email Preferred extremity view Graph preferences

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This is your RTILink login ID and is often your first initial and last name. This needs to be a valid email address. If checked, a regular email will be sent to your email address summarizing the progress of your patients. Select either legs or arms as your default RT300 therapy view. Check this if you prefer a white progress and session graph background for printing.

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Creating a New Patient Record on RTILink Follow these steps to create a new patient record which will include one or more default therapies: 1. Use your web browser to access www.RTILink.com 2. Log in to this site using your username and password • Your username is usually your first initial and last name 3. Select Patients from the menu bar • A page displaying all the existing patients for your clinic will be shown 4. Select “Add a patient” from the top of the left hand column 5. Complete the patient details as shown below • At a minimum, uncheck the email subscription checkbox if a patient email address is not entered • Additional data entry is optional • Press the Save button 6. The ID number for the new patient is shown at the top of the new patient detail page. A default therapy has been created for the new patient. This can be edited by either: a) Click on the “Default” therapy on RTILink to edit on the web site OR b) Login on the controller using the clinician code and open the patient using the new ID number to edit on the controller

Figure 1 RTILink new patient page 2005-2011 Restorative Therapies Inc

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Patient Clinic ID # Pediatric Clinician RT300 legs Default muscle assignment Therapy template RT300 arms Default muscle assignment Therapy template RT200 Default muscle assignment Therapy template RT600 stepping Default muscle assignment Therapy template RT600 standing Default muscle assignment Therapy template Email Subscribe to progress email Country PIN number Neurological Condition ASIA Level Weight Session efficiency

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This is an OPTIONAL cross reference to your clinic’s medical record number Check this box if you want SAGE to have pediatric default settings for this patient Select the clinician for this patient Check this if the patient will use the RT300 leg cycle This is set to bilateral or unilateral left or right or no stimulation. Use this drop down box to select the template that you want to base this patient’s initial therapy on. You can create new templates as required. Check this if the patient will use the RT300 arm cycle This is set to bilateral or unilateral left or right or no stimulation. Use this drop down box to select the template that you want to base this patient’s initial therapy on. You can create new templates as required. Check this if the patient will use the RT200 elliptical This is set to bilateral or unilateral left or right or no stimulation. Use this drop down box to select the template that you want to base this patient’s initial therapy on. You can create new templates as required. Check this if the patient will use the RT600 for stepping This is set to bilateral or unilateral left or right or no stimulation. Use this drop down box to select the template that you want to base this patient’s initial therapy on. You can create new templates as required. Check this if the patient will use the RT600 for standing This is set to bilateral or unilateral left or right or no stimulation. Use this drop down box to select the template that you want to base this patient’s initial therapy on. You can create new templates as required. Patient’s email address for progress emails Check this if the patient would like to receive progress emails Uncheck this box if you do not enter a patient email address Set this to the patient’s country of residence This is a PIN number that must be entered on the SAGE controller after the patient is opened. It is usually set to month and year of birth: mmyy. This is an OPTIONAL setting which allows enhanced outcome reporting. This is an OPTIONAL setting which allows enhanced outcome reporting. This is an OPTIONAL setting which allows enhanced outcome reporting. This is an OPTIONAL setting which is used by RTILink for MET calculations and RT600 for weight bearing. This is an OPTIONAL setting which is used by RTILink for MET calculations. It is the estimated metabolic efficiency of the patient’s sessions. For FES cycling when the activity is fully FES evoked this is probably approximately 6%. For fully volitionally evoked cycling this is approximately 25%.

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Clinician login on the Sage controller To login press Clinician and then Clinician Log in…

Figure 2 Log in menu

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Once you login, configuration pages are accessed by pressing the configure button

Figure 3 Login page

Enter the clinician login code 1776 and then press OK

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System Settings System settings are parameters, which change the way SAGE will operate for all patients. The system settings are accessed from the controller main page menu as shown below:

Select System | System Settings … Figure 4 Accessing the System page

Tap here to cancel any changes.

Tap here to save.

Figure 5 System page

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Parameter Turn off backlight TimeZone Language Use Remote Database

Always use previous therapy if download fails RTI home Patient ID PIN Access Point PassCode

Description If checked the screen dims after a session is completed. Also allows setting of the amount of time before the dimming takes place. Specifies the local time zone. This is used to adjust the time obtained by SAGE from the remote database. Allows selection of the language to be used by the SAGE system. If checked, SAGE will integrate with RTI’s remote database. A internet connection to www.RTILink.com is required for this option. A patient ID and PIN will need to be entered prior to starting each therapy session. If checked and Sage is unable to download therapy parameters at the beginning of a session (e.g. if the Internet connection is down) then the patient’s last settings on this machine will be used.

Units min

Range 1-5

Increment varied

Default 5

-

-

-

US EST

-

-

-

-

-

-

-

Not checked

Specifies the patient ID of a patient for a home based (single patient use) system. Specifies the patient PIN of a patient for a single patient use system. If a BlueTooth access point is used to connect to the internet, the device’s BlueTooth passcode is entered here.

-

-

-

Blank

-

00009999 -

1

Blank

-

rti

Not checked

-

Table 2. System parameters

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Real time stimulation adjustment If you are logged into the Sage controller as a clinician, it is possible to make adjustments to the stimulation levels during a therapy session. The clinician login process is described on page 11.

Figure 6 Session starting with real time adjustment enabled

Tap on this button to adjust stimulation parameters during a session.

Tap on this button to stop the maximum stimulation level increasing during Active Transition.

If you tap on the real time adjustment button the channel configuration page will be displayed. This allows you to make changes to stimulation parameters during the session. The operation of the channel configuration page is described on page 18.

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Configuring the system Important note: If therapy changes are made for a patient using www.RTILink.com while the patient’s record is open on the SAGE controller, any therapy changes made using the SAGE controller will not be saved in the remote database. This is because priority is given to therapy changes made using www.RTILink.com.

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Stimulator settings Adjust just one or a set of channels together

Change max stimulation level. Change min stimulation level. Tap on a channel to select muscle Figure 7 Stimulator page

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Tap a hyperlink to change pulse width or frequency