SAGE User Guide Issue 5

About SAGE ...1   SAGE software ...1   SAGE Controller ...1   Before You Start...5   Taking care of the SAGE controller ...5   Configuring SAGE ...6   Preparing for Therapy ...11   Selecting the right electrodes for your therapy...11   Attaching the electrodes to your skin...12   Connecting electrodes to stimulation cable and SAGE controller...13   Where to place the electrodes ...13   Therapy ...18   Things to know before you start...18   Phases of therapy...19   Your therapy session...20   Adjusting your therapy...22   Using the Accessories ...24   The pulse oximeter ...24   RT50 stimulator ...27   Replacement Electrodes, Spare Parts and Accessories ...32   Symbols...34   Technical Specifications ...35   Technical Support ...36   RTI technical support...36   Warranties and Contact Details...37  

About SAGE SAGE therapy sessions help you to move using your own muscles in order to provide you with improved range of motion and local circulation, reduced spasticity, and reversal of muscle atrophy. SAGE does this by providing Functional Electrical Stimulation (FES). The electrical stimulation signals your muscles to contract by stimulating your peripheral nerves. The SAGE System is supplied with pre-set (default) therapy settings. Your clinician may also make adjustments such as: • • •

Length of your therapy session How much power your muscles generate or, if using the RT600, how much of your weight you bear, during a therapy session Interval therapy to change the speed and resistance at set times during your therapy session

SAGE software SAGE is the software we use to control your ergometer. It gives you and your clinician the ability to set up and adjust various parameters of your therapy, add and remove accessories, connect to RTILink.com to back up your data, and to allow you and your clinician to monitor your therapy from a distance. The main function of SAGE is to control the electrical stimulation you receive. This guide explains how to use SAGE and includes information on how to: • • •

Set up the controller and electrodes in the best way for your therapy Ensure that your therapy is as safe as possible Remedy any simple problems that occur during therapy

SAGE Controller The SAGE controller’s therapy screen shows what is happening at any particular time during a therapy session.

Touch-sensitive therapy screen SAGE uses a touch-sensitive screen that you can operate to access the following features: • • • •

Start and stop your therapy session Monitor the progress of your therapy session See any warnings or errors that occur Update your stimulation parameters

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The Therapy Screen

Variations in the Therapy Screen for the RT600

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Features of the therapy screen are defined below. Actual Speed indicator: Shows the actual speed you are achieving with your therapy Asymmetry Display: Shows you the difference in work being done by the limbs on the left and right side of your body Change Direction button: Only displays on arm sessions where it can be used to change the direction of the ergometer from forward to backward or backward to forward Clinician Indicator: Indicates (with “Rx”) that a clinician is logged into SAGE Control Speed display: Controls the speed of your therapy with + and – buttons for increasing and decreasing the speed (if enabled by your clinician) Cool Down button: Used to progress straight to the Cool Down phase from any point during your therapy Get In button: Used to move the footplates of the RT600 into a comfortable position for getting in Go or Stop button: Starts or stops the session – the button toggles between Go and Stop depending on the status of the session Home button: used on startup to move the footplates of the RT600 to the home position Internet Connection button: Enables SAGE to connect to RTILink.com (appears in grey when disconnected) Menu bar • • •

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Clinician menu: Allows the clinician to log in and out of the SAGE controller in order to enable and disable the clinician functions Patient menu: Used on a home system to change your patient PIN, and on a clinic system to open and close patient records Therapy menu: Allows you to display the configured electrode placement, view the last session summary, and select between leg and arm therapy (if your ergometer supports both) System menu: Allows you to configure RT50 stimulators, set system options (such as the time zone), add a pulse oximeter, calibrate the ergometer, and synchronize the SAGE software and system settings to those saved in RTILink Help menu: Accesses the Help functions and information about SAGE

Motor Indicator: Displays blue when the motor is assisting and grey when not assisting Patient ID: Identifies the patient for whom SAGE has been configured to work Power display: Shows how much power is being delivered to the ergometer

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Pulse Oximeter display: Shows the serial number of the pulse oximeter (so you can check that you are using the right one) along with your pulse rate and oxygen saturation Resistance display: Shows the resistance level in Nm and + and – buttons for adjusting it up and down (if enabled by your clinician) Skip to next interval: If your therapy includes intervals this button will allow you to skip to the next interval at any time Standby button: Closes the current patient record Status and Error display: Shows the current status and any error messages Stimulation Graph: Shows the level of stimulation from 0% to 100% - Off when no stimulation is present, and Min when the minimum stimulation configured for your therapy is being applied Stimulation Indicator: Shows when electrical stimulation is being applied to your body – or half of your body if only half of the indicator lights up Stride Length: Shows the length of gait to be used for your therapy – you must set it to match the length set on the RT600 crank arm, as explained in the RT600 User Guide Target Speed display: Indicates the desired speed for your therapy with + and – buttons for increasing and decreasing the target (not shown for all therapies) Target Weight Bearing display: Shows the target for the percentage of your weight that your legs will support during therapy Therapy Configuration button: Displays the therapy options currently available which are six bars and lightning bolt to indicate that full and real-time configurations are available when the clinician is logged in, and three bars to indicate when limited patient therapy options are available Up and Down timer: Shows how much time has elapsed since the beginning of the therapy session (Up mode) and how much time remains (Down mode) Weight: Measures the weight of the RT600 user for an RT600 therapy session (see the RT600 User Guide for more information) Weight Bearing display: Indicates the percentage of your weight that your legs are actually supporting during therapy

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Before You Start Before you start using your FES system you should: • • • •

Read this guide because it applies to all of our SAGE FES systems Read the user guide for your ergometer as it will contain extra information specific to your device that is not contained in this guide Ask your clinician for training in how to get started Ask your clinician to explain anything in this guide that you do not understand, particularly how any cautions, warnings and safety measures relate to you

In your ergometer user guide, please pay special attention to sections about: • • • •

Indications for use Contraindications Cautions Warnings and safety measures

Taking care of the SAGE controller How to clean your SAGE controller • • •

Wipe the touch screen with a damp cloth From time to time, clean any surfaces that come into contact with the user using 70% isopropyl alcohol or standard rubbing alcohol Be careful not to damage or remove any labels during cleaning

Never use solvent-based or corrosive cleaners on any components Always unplug your SAGE system from the electrical supply for cleaning

Maintaining your system • •

SAGE does not require any periodic maintenance Your ergometer may require maintenance – the instructions for maintaining your ergometer are in the ergometer’s user guide

Storing the SAGE controller Always store your SAGE controller at a temperature between -40ºF (-20ºC) and +122ºF (50ºC).

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Configuring SAGE Accessing the RTILink.com database If you have an Internet connection, you can connect SAGE to the RTILink.com database. This feature works best with a permanent Internet connection, such as DSL or cable, although you can use it with a dial-up connection too. Connecting to RTILink.com gives you the ability to: •

• • •

Load your most recent therapy parameters into SAGE before starting a session – these may include changes to your therapy made remotely by your clinician Save any therapy changes you make during your session to the database for safe keeping Save your session logs for you and your clinician to view at www.RTIlink.com Update your SAGE system software to the latest version and set SAGE’s clock

Depending on the information that you provided to Restorative Therapies Inc (RTI) when you purchased your system, it will be configured to do one of the following: • • • • •

Not connect to the Internet at all (stand-alone operation) Connect to the Internet via a wired 10Base-T Ethernet connection Connect via an existing WiFi network Connect via WiFi to an RTI-supplied WiFi router Connect via a Bluetooth dial-up modem using your dial-up Internet account

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Use RTILink.com

Setting up RTILink operation 1. Open the RTILink.com setup page by tapping the Internet connection button – the icon is grey indicating the RTILink.com connection is turned off. The setup window appears. 2. Check Use RTILink.com. This will allow SAGE to automatically sync with RTILink.com. On a home system, a pop-up keyboard appears. 3. Type your patient ID number into the RTI home patient ID box. (Your Patient ID is the seven digit number that your clinician or RTI gave you. You can leave out the leading “1s” and “0s.”) 4. Type your PIN into the PIN box (If you have not set a PIN before, try the default PIN of MMYY where MM is your birth month and YY your birth year.) 5. Tap the green check mark 6. The Internet connection button turns blue to indicate that RTILink is enabled. 7. The Internet icon can show two statuses

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RTILink.com connection is enabled and working

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RTILink.com connection is enabled but not working

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Using SAGE without RTILink.com connected You can turn off the RTILink.com connection and operate SAGE in stand-alone mode. In this stand alone mode you can still elect to use or not use Patient ID numbers (see below) however data will not be synced with RTILink.com Typically, you would do this when you no longer have an Internet connection available or you have a long term problem with your Internet connection and do not want to wait for SAGE to attempt to connect prior to each session. 1. 2. 3. 4.

Tap the Internet icon to open the setup page Uncheck the Use RTILink.com box Tap the green check mark to close the box The Internet icon turns grey to indicate that the RTILink.com connection is turned off

Using SAGE with and without Patient ID numbers You can elect to operate SAGE with or without Patient ID numbers. If you elect to use Patient ID numbers you can either select from the Patient ID numbers available loaclly on the SAGE or from any Patient ID number if RTILink is connected (see above). You might want to select not to use Patient ID numbers if for example you wanted to run a test session and did not want to effect any Patient settings. To change this setting: 1. Tap the Patient menu item atn the top of the screen 2. Tap either • "Use Sage Without Patient ID to operate Sage using Patient ID numbers • "Use With Patient ID" to operate without using or effecting a Patient ID

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Connecting to WiFi Connecting your SAGE controller to a wireless network (WiFi) allows you to access RTILink. Follow these steps to connect to WiFi: 1. Tap the Internet icon. 2. Tap the hyperlink Show WiFi Manager to make the WiFi manager and keyboard appear. 3. To connect to a network, highlight the name of the network in the Access Point List (tap the Refresh button if not seen) and tap the Connect to Access Point button. 4. Secure WiFi networks require you to enter a password or network key into the Network Key box. Use the keyboard to enter the letters and numbers, and tap Connect when you are finished. 5. When you are satisfied with your settings, tap the X that appears in the top right of the WiFi Manager window. 6. Finally, tap the green check button to complete the setup.

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Setting (or changing) your PIN To set or change your PIN, follow the steps below. 1. Tap Patient then Change PIN in the top left of the screen. The Confirm PIN box appears so that you can confirm your current PIN before you change it (this makes it difficult for other people to change your PIN without you knowing) 2. Enter your current PIN by tapping the numbers on screen (If this is your first time entering your PIN, enter the default PIN of MMYY where MM is your birth month and YY is your birth year.) 3. Tap OK when you are finished. A new box will appear, asking you to enter your new PIN. 4. Tap the numbers to enter your new PIN 5. Tap OK when you are finished. The box will appear again, asking you to confirm your PIN 6. Type your PIN again 7. Tap OK when you are finished

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Preparing for Therapy Selecting the right electrodes for your therapy SAGE provides stimulation through adhesive electrodes placed on the skin over muscles selected by your clinician. The way your clinician has configured your therapy and the type of ergometer you are using will define which muscles are available for stimulation. Electrodes are available in a range of sizes to suit the size of the muscle that needs to be stimulated. You will typically need to use larger sized electrodes on your quadriceps and hamstrings than other muscle groups. Your clinician will usually aim to cover a good portion of the muscle that they intend to stimulate while avoiding any other muscles or touching other electrodes.

Upper extremity (arm) stimulation • • • • • • •

Right and left biceps Right and left triceps Shoulder (up to 2 channels per shoulder) Right and left anterior deltoid Right and left posterior deltoid Right and left wrist flexors / grip Right and left wrist extensors / release

Core muscle stimulation • •

Right and left erector spinae Right and left abdominals

Lower extremity (leg) stimulation • • • • •

Right and left gluteals Right and left hamstrings Right and left quadriceps Right and left gastrocnemius (gastroc) Right and left anterior tibialis

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Attaching the electrodes to your skin 1. Make sure the skin where you want to put the electrodes is clean and dry – remove any lotion with an alcohol wipe. 2. Peel the electrodes off the plastic film carrier 3. Place the two electrodes on your body at the correct location as shown in the following sections. A video demonstration is available on RTILink.com on the Education page 4. Use your finger to gently press around the entire surface of the electrode to make sure it is in full contact with your skin 5. Repeat steps 2 to 4 for the remaining pairs of electrodes

Tips for attaching, detaching, and caring for your electrodes • • •

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Only use electrodes supplied by RTI – they are the only electrodes that have been tested for use with your ergometer. Hair under the electrode may prevent it from adhering to your skin, so trim hair from the electrode site if the electrode does not stick properly Check your skin at each electrode site after each therapy session. If the skin is irritated, move the electrode to a slightly different area on the same muscle next time. Contact your clinician if the irritation continues. Do not use any electrodes that are smaller than those prescribed with SAGE as they could cause irritation or burning. The adhesive gel on the electrode typically lasts for 10 to 15 uses. Replace the electrode if it loses stickiness or after 15 uses. • • • •

• • •

Keep track of how many times you use each electrode by marking their bag with a check mark each time you use them If the electrode fails to make full contact with your skin, or it fails to adhere to your skin, replace the electrode Replace any electrodes with rough edges Electrodes on your gluteal muscles wear faster than others so check them more often

Gently peel the electrode from the corner to remove it from your skin Do not pull on the connecting lead as this may damage the connection between the lead and the electrode Replace electrodes onto their plastic carriers (place them onto the side labelled “ON”) and store in their sealed bags when they are not in use. •

If the plastic carrier says “NO” turn it over and stick the electrode to the other side

See the electrode pack for more instructions on use, care, and storage

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Connecting electrodes to stimulation cable and SAGE controller Connecting electrodes The electrode leads from the stimulation cable are numbered. Use this as a guide to where to place the electrodes. 1. Connect the leads from the stimulation cable to the electrodes placed on your body – make sure the pins on the end of the leads are fully inserted into the plugs by pressing down with your finger tip 2. Plug the stimulation cable into the outlet on the bottom of the SAGE controller with the arrows on the plug facing towards you – you will feel a click when it is correctly attached

Disconnecting electrodes When disconnecting the electrodes from the stimulation cable, hold the finger grips on the stimulation cable lead and pull gently on the grey electrode lead. This disconnection technique helps protect your stimulation cable from damage.

Where to place the electrodes You must use your FES system with the electrodes fitted to the parts of your body indicated on the muscle assignment sheet supplied with your system. The muscle assignment sheet (right) shows you which muscle groups your clinician has configured for stimulation.

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Placement of Electrodes for Bilateral Arm Stimulation Posterior View These diagrams show a posterior view of the electrode placement for bilateral arm stimulation Triceps electrodes (blue channels) Shoulder electrodes (yellow channels)

The dotted lines indicate alternative shoulder placements

Anterior and Side Views Triceps electrodes (blue channels) Shoulder electrodes (yellow channels) Biceps electrodes (red channels)

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Placement of Electrodes for Unilateral Arm Stimulation Front and Side Views This diagram shows electrode placement for right arm stimulation. Triceps electrodes (blue channels) Shoulder electrodes (yellow channels) Biceps electrodes (red channels) Anterior deltoid electrodes (orange electrodes) Posterior deltoid electrodes (green electrodes)

Placement of Electrodes for Forearm Stimulation for Wrist Flexion and Extension Front and Back This diagram shows electrode placement for right arm stimulation. Wrist flexion electrodes (red channels) Wrist extension electrodes (blue channels)

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Placement of Electrodes for Forearm Stimulation for Grasp and Release Front and Back This diagram shows electrode placement for right arm stimulation. Grasp electrodes (red channels) Release electrodes (blue channels)

Placement of Electrodes for Abdominal Stimulation Abdominal stimulation can be configured during both leg and arm therapy. Place the electrodes beneath the ribs. Right abdominal electrodes (red channels) Left abdominal electrodes (blue channels)

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Placement of Electrodes for Unilateral Leg Stimulation This diagram shows electrode placement for right arm stimulation. Quadriceps electrodes (red channels) Tibialis Anterior electrodes (green channels) Gluteal electrodes (yellow channels) Hamstrings electrodes (blue channels) Gastrocnemius electrodes (orange channels)

Calf electrodes can be placed vertically over the muscle belly, shown in yellow

Placement of Electrodes for Bilateral Leg Stimulation Use vertical or horizontal gluteal electrode placement as instructed by your clinician. Quadriceps electrodes (red channels) Gluteal electrodes (yellow channels) Hamstrings electrodes (blue channels)

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Therapy The SAGE System is supplied with pre-set (default) therapy settings and your clinician may also make adjustments such as: • • •

Length of your therapy session How much power your muscles generate during a therapy session Interval therapy to change the speed and resistance at set times during your therapy session

Things to know before you start Built-in safety measures SAGE has a number of built-in safety measures to protect you during therapy: •

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If the system registers that your muscles are fatigued during therapy, the stimulation switch off and the motor in the ergometer will take over for the remainder of the session. You will know this has happened when the message on the display changes from Active therapy to Passive therapy. If an electrode falls off or becomes disconnected from the cable, the system will pause your therapy by stopping stimulation and switching off the motor. An error message on the controller lets you know what has happened. You can re-attach or replace the electrode and tap Go to continue your therapy. If the system detects that your muscles have gone into spasm it will pause your therapy by stopping stimulation and turning off the motor. A message on the controller lets you know what has happened.

How to handle a muscle spasm if it occurs during therapy If you are going to have a muscle spasm it is most likely to happen at the beginning of the Warm Up phase or during Active Transition, although it may happen at other times too. Stretching before your session may help reduce muscle spasms. Also your clinician can adjust your therapy settings to reduce the likelihood of muscle spasms occurring. When it detects a muscle spasm, SAGE will pause the therapy session. SAGE recognizes a muscle spasm when the ergometer slows suddenly or the speed drops below 10 rpm. If you detect a muscle spasm before SAGE does, tap the Stop button If your muscle spasms persist, pause for five minutes before tapping Go to restart your therapy. If the spasms do not subside, postpone your therapy and talk to your clinician.

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