Restorative Therapies RT300 User manual

RT300 User Guide
© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
™
User
Guide
This guide should be read in conjunction with the SAGE™ user guide.
Caution for RT300 users in the USA:
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 or she
practices to use or order the use of the device.

RT300 User Guide
© Restorative Therapies Inc. 2005-2016. LB10010 Version 37 ii
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RT300 User Guide
© Restorative Therapies Inc. 2005-2016. LB10010 Version 37 iii
Symbols
Symbol Meaning
Fragile
or
See instructions for use
Manufacturer
Date of manufacture
Temperature rage
Lot number or batch number
or REF Reference number or part number
Model SA109413 Model number
Type BF applied part – part of the RT300 that comes in
contact with the patient; for example, the pedals,
touchscreen and stimulation cable.
Double insulated or class 2 electrical appliances are
products that have been designed in a way so as not to
require a safety connection to electrical earth
Warning high voltage
Keep Dry
Do not throw in trash
Interference may occur in the vicinity of equipment
marked with this symbol

RT300 User Guide
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Table of Contents
Symbols ............................................................................................................................................... iii
About RT300 ........................................................................................................................................ 6
RT300 overview ............................................................................................................................... 7
RT300 pediatric ...............................................................................................................................
Before You Start ................................................................................................................................. 9
Before you start using RT300: ........................................................................................................ 9
Statement of Intended Use – what RT300 is used for ................................................................ 9
Contraindications – when you must NOT use RT300 ............................................................... 10
Warnings ........................................................................................................................................ 11
Cautions ........................................................................................................................................ 12
Potential Adverse Reactions ...................................................................................................... 13
Safety Measures ........................................................................................................................... 14
Taking care of your RT300 System .................................................................................................. 17
Storing RT300 ................................................................................................................................. 17
Moving RT300 System ................................................................................................................... 17
Shipping RT300 .............................................................................................................................. 17
Cleaning ........................................................................................................................................ 17
Calibration and maintenance of RT300 ................................................................................... 1
Assembling your RT300 .................................................................................................................... 22
Connecting the Power ................................................................................................................... 23
Before your first therapy session ..................................................................................................... 23
Adjust the floor mounted leg ergometer to fit you ................................................................. 23
Pediatric adjustments .................................................................................................................. 26
Adjust the floor mounted arm ergometer ................................................................................ 2
Using RT300 ........................................................................................................................................ 29
Using RT300 Restraints .................................................................................................................. 29
Position yourself on your floor mounted RT300 Leg Ergometer .............................................. 30
Positioning on your floor mounted RT300 Arm Ergometer ...................................................... 31
Positioning on RT300 supine ........................................................................................................ 32

RT300 User Guide
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Working with SAGE ....................................................................................................................... 35
Troubleshooting RT300 ..................................................................................................................... 36
Internet connection ..................................................................................................................... 36
Other issues ................................................................................................................................... 37
RT300 Spare Parts and Accessories ............................................................................................... 40
Technical Information ..................................................................................................................... 45
Technical Support ............................................................................................................................ 52
RTI Technical Support .................................................................................................................. 52
Disposal .......................................................................................................................................... 52
Warning ......................................................................................................................................... 52
Service ........................................................................................................................................... 52
Warranties and Contact Details .................................................................................................... 52

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
About RT300
RT300 is a motorized therapy system, which utilizes Functional Electrical Stimulation (FES)
to assist you to cycle on a motorized ergometer.
RT300 is designed to provide a therapy prescribed by your clinician.
This therapy can be:
•passive therapy – where the motor moves your limbs without stimulation
being applied
•active therapy – where electrical stimulation enables your muscles to work
•a combination of active therapy with the motor providing some assistance
RT300 is used from your chair, wheelchair, or bed and there are two variants, which can
be used individually:
•The leg system where your feet are secured in the pedals and legs
supported by the calf rests
•The arm system with your hands are around the arm crank’s hand grip and
your arms supported by optional arm rests
Adhesive electrodes placed on your skin over particular muscle groups are connected
to RT300 by a cable or wirelessly. These are used to stimulate peripheral motor nerves
causing your muscles to contract.
Software in RT300’s SAGE controller controls your therapy including the stimulation
patterns sent to your arms or legs and the operation of the ergometer’s motor to
produce a smooth cycling motion.

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
RT300 overview
Floor mounted: RT300-SL RT300-SLSA
Table mounted: RT300-SA RT300 Supine

RT300 User Guide Page
© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
RT300 pediatric
RT300 pediatric models are designed for children aged between four and 12 years and
include as standard equipment:
•Pedals that are able to be adjusted to accommodate a range of
orthopedic issues and smaller sizes
•Arm crank adjustable radius to accommodate for smaller limb lengths
Floor mounted: RT300-SLP

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Before You Start
This guide explains how to use RT300 including:
•How to set up and use the equipment
•Safety measures that help you use RT300 safely
•How to fix basic problems that may occur
RT300 generates currents that could electrocute you if used improperly!
Before you start using RT300:
•Read this guide – particularly the Statement of Intended Use,
Contraindications, Cautions, Warnings and Safety Measures sections
•Talk to your clinician who can explain how these sections relate to you
•Assemble your system as per the accompanying RT300 assembly instructions
•Read the accompanying SAGE User Guide
Statement of Intended Use – what RT300 is used for
RT300 is intended for general rehabilitation for:
•Relaxation of muscle spasms
•Prevention or retardation of disuse atrophy
•Increasing local blood circulation
•Maintaining or increasing range of motion
RT300 pediatric version is intended for population ages 4 to 12 years.
RT300 is intended for use with a surface electrical stimulation garment for population
ages 12 and above.
Powered muscle stimulators should only be used under medical supervision for
adjunctive therapy for the treatment of medical diseases and conditions.

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Contraindications – when you must OT use RT300
You must NOT use RT300 if:
•You have a cardiac demand pacemaker
•You have unhealed fractures in your lower extremities
•You are pregnant as we do not know whether the electrical stimulation is
safe for your unborn child
You must NOT use RT300 for upper extremities if:
•You have a grade three tear or greater of either rotator cuff
•Shoulder subluxation which cannot be corrected with electrically evoked
contractions or other means such as a sling or taping
• You have unhealed fractures in your upper extremities, shoulder girdle or
upper ribs
Relative Contraindications – things that may increase the risk of
using RT300 although the benefit may outweigh the risk
1. Denervated muscles may not contract in response to stimulation
2. Spasticity will not usually prevent you from using RT300 although you may need to
undertake a stretching program prior to therapy and your therapy settings may
have to be modified to reduce the probability of spasm
3. Heterotopic Ossification/Limited Range of otion should not cause problems if
you can be positioned in your chair to accommodate your range of motion
limitations:
4. At least100 degrees of hip and knee flexion is recommended for leg therapy
without the need for special positioning
5. At least 90 degrees of shoulder flexion and 125 degree of elbow flexion is
recommended for upper extremity therapy without the need for special
positioning
6. Severe Osteoporosis that has progressed to the point where there is an increased
risk of fractures will require the therapy to be adjusted to account for the degree
of osteoporosis
7. Dysesthetic Pain Syndrome may worsen in response to stimulation using RT300
and cause therapy to be too uncomfortable to continue
. Pressure sores or open wounds in area of treatment should heal before RT300 is
used
9. Implanted plates, pins, screws and other hardware must have been in position for
three months before RT300 is used on the affected limbs
10. Implanted stimulators such as vagus nerve, phrenic, cardiac, cochlear,
diaphragmatic stimulators with upper extremity FES
11. alignancy please consult your physician prior to use

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Warnings
If your blood pressure or heart rate reaches a level that the clinician considers unsafe,
or if you feel faint, light headed or nauseous, stop the therapy session immediately and
take appropriate medical action
1. RT300 is a prescribed device. It should not be given to or shared with other
individuals
2. You should always wear shoes (e.g. running or tennis shoes), and socks to protect
your feet and ankles and secure your shoes and shoelaces with the Velcro straps
when using RT300 leg system. When using in a supine position with bare feet
protective inserts must be fitted
3. When using the RT300 arm system, or in a supine position continuous assistance
must always be available because while using the device it may not be possible
for you to stop the therapy
4. Some medical conditions can be aggravated by physical activity. If symptoms
of a medical condition occur during or after a therapy session, consult your
clinician immediately
5. If directed by your clinician, your blood pressure and heart rate should be
monitored during the therapy session
6. The long-term effects of chronic electrical stimulation are unknown
7. Stimulation should not be applied over your carotid sinus nerves (neck),
particularly if you have a known sensitivity to the carotid sinus reflex
. Stimulation should not be applied over your neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be
strong enough to close the airway or cause difficulty in breathing
9. Stimulation should not be applied trans-thoracically (across the chest) because
the introduction of electrical current into the heart may cause cardiac
arrhythmias
10. Stimulation should not be applied trans-cerebrally (to the head)
11. Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
12. Stimulation should not be applied over, or in proximity to, cancerous lesions
13. Electrode placement and stimulation settings should be based on the guidance
of the prescribing practitioner
14. Simultaneous connection of a patient to a high frequency surgical ME Equipment
and the stimulator may result in burns and possible damage to the stimulator
15. Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME
Equipment may produce instability in the stimulator output
16. Powered muscle stimulators should be kept out of the reach of children. Children
should only use this device under adult supervision. Never leave RT300
unattended when children are present
17. Powered muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer and which are in good condition
1 . If using electrodes that have current densities that exceed 2ma/cm
2
may require
special attention by the operator

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
19. Use caution when operating your RT300 in the presence of pets as moving parts
may lead to injury
Cautions
You should use RT300 with caution if you:
1. Have ANY implanted medical device
2. Have suspected or diagnosed heart problems
3. Have suspected or diagnosed epilepsy
4. Have high fever, high blood pressure, or high heart
5. Have respiratory complications
6. Have a cancerous lesion, noting especially that stimulation should not be
applied over, or in proximity to, cancerous lesions
7. Have an infection in the area of electrode placement
. Have a urinary tract infection as this may increase the probability of autonomic
dysreflexia during a therapy session
9. Have an acute hip replacement
10. Have a hip fracture
11. Have spondylolisthesis
12. Have a tendency to hemorrhage following acute trauma or fracture
13. Have had a recent surgical procedure and muscle contraction may disrupt the
healing process
14. Have a history of:
a. Orthostatic hypotension or autonomic dysreflexia
b. Hip or knee dislocation or subluxation
c. Upper or lower limb stress fractures
d. Severe spasticity or spastic response to application of electrical
stimulation
e. Compromised skin integrity
15. Guidelines for undertaking kinetic exercise should be considered
1
.
1
American College of Sports Medicine, Guidelines for Graded Exercise Testing and Exercise
Prescription, 4th Edition. Lea & Febriger, 1991

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Additional Cautions for Upper xtremity rgometry with Children
Torus Fractures have been reported in children during upper extremity
ergometry. Torus fractures, also known as buckle fractures or incomplete
fractures, occur when the child’s bone, which is softer than an adult’s, buckles or
bends back upon itself without breaking the other side of the bone. They are
common injuries seen in children. To reduce the chance of wrist injury of this kind,
ensure that:
•Your child’s wrists are well supported during upper extremity
ergometry
•Your child always uses the hand, wrist and arm adaptations
recommended by the clinician
•Your child remains seated straight-on to the ergometer – avoiding
any twisting motion in their forearm and wrist
If your child complains of wrist pain or if notice any swelling of a wrist during or
after upper extremity ergometry consult your clinician immediately.
Potential Adverse Reactions
Autonomic Dysreflexia
If you have a spinal cord injury at or above the T6 level then you may be prone to
autonomic dysreflexia (AD), which can be triggered by electrical stimulation. If you
have a spinal cord injury you must discuss autonomic dysreflexia with your clinician so
that you understand how it may impact you so that you know:
•How to recognize the signs of autonomic dysreflexia
•How to react if it occurs, including stopping electrical stimulation
You can reduce your chances of experiencing autonomic dysreflexia by following
these precautions:
•Empty your bladder and bowels before commencing an RT300 therapy
session
•Do NOT use RT300 if you have a bladder infection or fever.
Carefully note any symptoms of autonomic dysreflexia that occur during a therapy
session – it can occur during a session even if you have not experienced it before or
recently.
The vital signs display and alarms from the pulse oximeter provide outcome data from
your therapy session – they are not a substitute for careful monitoring for any signs of
autonomic dysreflexia or other health related issues.
Parents: Common signs of AD in children include headache, dizziness, blurred vision,
redness of the face, neck, ears, feeling hot, and sometimes goose bumps, an upset
stomach, or tingling feelings.

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Skin irritation and burns
You can move the electrode to a new location or use a sensitive skin electrode to
reduce any sensation of irritation or burning caused by the electrical conductive
medium (adhesive gel) or the electrical stimulation.
Do not use electrodes more often than recommended by their manufacturer. Do not
use electrodes that are expired, not in good condition, including condition of the
adhesive gel.
Thermal Dysregulation
You can reduce the impact of thermal dysregulation or overheating by exercising in an
environment where temperature and humidity are controlled, paying careful attention
to maintaining hydration and limiting the duration and intensity of exercise in hot or
cold environments.
Safety Measures
lectrical Safety
Avoid flammable anesthetics: Never use the equipment where there is a flammable
anesthetic mixture containing air, oxygen or nitrous oxide
Connecting the system: Connect the system parts only as described in this guide and
do not connect or disconnect any parts while the system is turned on
Protective Earth: To void risk of electric shock, the RT300 must only be connected to a
supply mains with protective earth
Other equipment: Do not use the system with any equipment not supplied by
Restorative Therapies Inc. as doing so could affect the electrical safety of the system
System parts: The system contains complex electronic parts which must be serviced by
qualified service personnel. Do not open the casings yourself or allow another person to
open the casings as you, or they, may be seriously injured
lectrostatic Discharge
Always touch a metal part of RT300 before you touch the controller or fit any parts – this
will dissipate any electrostatic build-up that could otherwise damage electrical parts of
the system or the software in the controller
nvironment
Use on a stable surface: Position RT300 on an even, non-slip surface so that it remains
stable and does not move during use
Use an anti-slip device: You may wish to use an anti-slip device, such as a mat, to
prevent RT300 or your bed or wheelchair from moving backwards during therapy

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Avoid wet areas: Never use RT300 in wet or damp areas
Avoid heat sources: Always place RT300 away from heat sources such as radiators,
stoves and other objects that produce heat
Arrange the power cords carefully: Arrange the power cords so they will not be walked
on, tripped over or damaged by objects resting on it
Use the correct line voltage: Only connect RT300 to a grounded (earthed) power outlet
that uses the voltage shown on the product label
Follow extension cord ratings: If you plan to use an extension cord, make sure the plug
has three pins (i.e. the plug includes a third, protective earth pin)
Parts and Operation
Isolation from supply mains: RT300 can be disconnected from the mains power supply
by disconnecting the power supply cord. Do not position the RT300 to make it difficult
to remove the power cord
Do not use the SAGE controller for other purposes: Do not use the SAGE controller for
any other purpose – for example, to store documents or images – as it may alter how
the controller works
Do not use other controllers: Do not use another person’s controller as only your
controller has been programmed to deliver your therapy and give you the correct
stimulation
Before use: Let RT300 stand for around an hour before using for the first time or after it
has been transported over a long distance
After a long absence: You may find that your performance deteriorates if you do not
use RT300 for a prolonged period of time (e.g. a few months) so see your clinician for re-
evaluation and, perhaps, re-training before you start using the system again
Handle with care: Handle RT300 and its various parts carefully to reduce the risk of
damage and do not stand on the footrests or RT300’s plastic motor covers
oving parts: Do not touch the pedals or hand attachments when the RT300 is in
operation. Keep all non-involved body parts clear of the crank’s rotation when the
machine is in operation
Check for wear and tear: Carefully inspect each part of RT300 each time you use it and
contact RTI Technical Support – and stop using RT300 – if you notice any damage such
as cracks or breaks in the covering of a cable
Report changes: If you find any changes occur in how RT300 operates, stop using the
system and contact your clinician or RTI Technical Support
•Repairs to RT300 must only be carried out by properly trained specialists
• If RT300 produces abnormal noises or smells, or appears damaged or faulty,
stop therapy immediately, unplug the power cord and contact RTI Technical
Support

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Clothing: Dress comfortably to allow for the appropriate range of motion in your legs
and/or arms and avoid wearing anything that may catch or tangle in the moving parts
Shoe laces: Be careful to secure your shoe laces with the foot restraint Velcro straps so
that they cannot tangle in the pedal crank
lectromagnetic Compatibility ( MC)
RT300 needs special precautions regarding EMC.
Only use the accessories and cables specified or supplied by Restorative Therapies as
other parts or components may change RT300’s EMC characteristics unpredictably.
Electromagnetic interference (EMI) comes from transmitters such as radio and TV
stations, radio transmitters (HAM, CB and two-way radios) and cellular phones. To
reduce EMI risk:
•Do not operate handheld transceivers such as citizens band (CB) radios
while operating RT300
•Be aware of nearby transmitters, such as radio or TV stations
•Keep RT300 at least 20ft (6.5m) away from microwave ovens

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Taking care of your RT300 System
Storing RT300
When you are not using RT300 please store it in temperatures between –4°F (–20°C) and
+122°F (+50°C).
Moving RT300 System
To move your RT300 floor mounted system:
1. Lower the legs to their lowest position
2. Unplug the power cord from the power
outlet and RT300 System
3. Tilt RT300 onto its back so that the rear
wheels make contact with the ground
4. Two people are required to carry RT300
especially up or down stairs.
To move your RT300 table mounted system:
1. Unlock all the wheels
2. Unplug the power cord from the power outlet and wrap it around the power cord
holder
3. Ensure all securing straps are retracted
RT300 wheels are not suitable for the transport on uneven or rough surfaces. RT300 must
not be transported over obstacles such as thresholds.
Shipping RT300
RT300 should be shipped in its original packaging.
Contact Restorative Therapies for packaging instructions.
Cleaning
Restorative Therapies recommends that you clean the surfaces of RT300 that come into
contact with anybody who uses it. The SAGE controller touch screen must only be
cleaned with a damp cloth. You can clean other surfaces with alcohol (70% isopropyl
alcohol) or a germicidal disposable wipe. Do not use solvent-based or corrosive
cleaners on your RT300. Take care when cleaning around labels that you do not
accidentally remove them.

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
Gel pedal and calf rest inserts
Full cleaning instructions are available on the manufacturer web site
www.actionproducts.com
•Avoid alcohol-based or strong, undiluted disinfectants as they may harden the
flexible product surface or cause staining
•ALWAYS rinse products with clear water to remove any residue from cleaning/
disinfecting solution. Failure to do so could result in patient injury
•Do not use gas sterilization, autoclaving, washing or drying machine methods to
clean product as it will cause irreparable damage
•Temperatures of approximately 103°F/ 40°C are recommended maximum for
cleaning
Always disconnect mains power before you start cleaning
Calibration and maintenance of RT300
After a period of time your RT300 will display a message that it requires calibration. You
can also force a calibration sequence to start by tapping System then Calibrate
ergometer. When calibration begins, follow the on-screen instructions.
Arm ergometer calibration
1. Power on RT300 and wait for the main GO page to appear
2. Remove the arm handles from RT300
3. Tap System and then Calibrate Ergometer
4. Select Arm and then tap
Start Calibration
5. Lock the arm crank in
place by turning the
arm crank lock knob
until it “clicks into
place”
6. Click Crank is locked
and the calibration
process will commence
7. Wait for the calibration
to finish. Then tap Click
to continue

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© Restorative Therapies Inc. 2005-2016. LB10010 Version 37
. Release the arm crank
lock knob by pulling it
down and turning it ½
turn in either direction
9. Tap Click to close
dialog
10. Refit the arm handles. Be sure to tighten the retaining bolt well
Leg ergometer calibration
1. Power on RT300 and wait for the main GO page to appear
2. Remove the pedals from RT300
3. Tap System and then Calibrate Ergometer
4. Select Leg and then tap
Start Calibration
5. Lock the pedals in
place by attaching the
restraint to the crank
6. Click Crank is locked
and the calibration
process will commence
7. Wait for the calibration
to finish. Then tap Click
to continue
. Remove the restraint
from the pedal crank so
that it can rotate freely
9. Tap Click to close
dialog
10. Refit the pedals. Be sure to tighten the retaining bolt well

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Table mount ergometer calibration
1. Power on RT300 and wait for the main GO page to appear
2. Remove the pedals from RT300
3. Tap System and then Calibrate Ergometer…
4. Tap Start Calibration
5. Make sure that the
crank arm moves freely
6. Tap Tap to continue and
the calibration process
will start
7. Wait for the calibration
to finish.
. Tap TAP to close dialog
to exist the calibration
screen
9. Refit the pedals. Be sure to tighten the retaining bolt well