Restorative Therapies RT300 User manual

RT300
Patient Assessment

RT300 Patient Assessment CL100730 V9 iii
Restorative Therapies Inc. © 2005-2018
RT300 is a powered muscle stimulator and should only be used under medical supervision for
adjunctive therapy for the treatment of medical diseases and conditions.
RT300 is appropriate for children and adults.
US Patent pending 15/804,441
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.
Warning:Modification of this equipment will void your warranty.
Statement of intended use
RT300 is intended to be used for the following.
1. Muscle re-education
2. Relaxation of muscle spasms
3. Prevention or retardation of disuse atrophy
4. Increasing local blood circulation
5. Maintaining or increasing range of motion

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Restorative Therapies Inc. © 2005-2018
Table of Contents
1 HEALTH AND SAFETY........................................................................................................... 2
1.1 A BSOLUTE CONTRAINDICATIONS ( WHEN YOU MUST NOT USE RT300).................................... 2
1.2 W ARNINGS ......................................................................................................................... 2
1.3 P RECAUTIONS .................................................................................................................... 3
1.3.1 Nervous system/neurological considerations ............................................................. 3
1.3.2 Skeletal system.......................................................................................................... 5
1.3.3 Wounds, infections, or fever....................................................................................... 5
1.3.4 Implanted devices or recent surgical procedures ....................................................... 6
1.3.5 Cardiovascular and respiratory considerations........................................................... 6
1.3.6 Cancer....................................................................................................................... 6
1.3.7 Menstruation.............................................................................................................. 6
1.3.8 Skin sensitivity to electrical stimulation....................................................................... 6
1.3.9 Prolonged period of RT300 disuse............................................................................. 6
1.3.10 Prolonged exposure................................................................................................... 6
1.4 U PPER EXTREMITY THERAPY FOR CHILDREN ......................................................................... 6
2 RT300 PATIENT ASSESSMENT FOR SUITABILITY ............................................................. 7
2.1 G ENERAL CONSIDERATIONS ................................................................................................ 7
2.2 RT300 RANGE OF MOTION (ROM) EVALUATION .................................................................... 7
2.2.1 Leg ROM ................................................................................................................... 7
2.2.2 Arm ROM................................................................................................................... 8
2.3 P RE - TREATMENT SCREENING .............................................................................................. 8
3 TECHNICAL SAFETY ............................................................................................................. 9
3.1 E LECTRICAL S AFETY ........................................................................................................... 9
3.2 E NVIRONMENTAL SAFETY .................................................................................................. 10
3.3 O PERATIONAL SAFETY ...................................................................................................... 10
4 RTI SUPPORT....................................................................................................................... 11

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Restorative Therapies Inc. © 2005-2018
Before initiating RT300 FES therapy with a patient, please review the health and safety
considerations in Section 1 including absolute contraindications, warnings regarding use of RT300,
and precautions and conditions requiring special consideration. Section 2 provides specific patient
assessments for range of motion and pre-treatment screening. Finally, Section 3 reviews technical
safety including electrical, environmental, and operational safety when conducting RT300 FES
therapy.
1 H EALTH AND SAFETY
1.1 Absolute contraindications (when you must NOT use RT300)
Certain conditions contraindicate the use of RT300.
1. A patient must NOT use RT300 at all if any of the following is true.
a. He/she has a cardiac demand pacemaker.
b. She is pregnant - insufficient evidence is available regarding the safety of FES to an
unborn child.
2. In addition, a patient must NOT use RT300 for lower extremities if he/she has unhealed
fractures in the lower extremities.
3. Finally, a patient must NOT use RT300 for upper extremities if any of the following is true.
a. He/she has a grade three or greater tear of either rotator cuff.
b. He/she has shoulder subluxation that cannot be corrected with electrically evoked
contractions or other means such as wearing a sling or taping the extremity.
c. He/she has unhealed fractures in the upper extremities, shoulder girdle, or upper ribs.
1.2 Warnings
1. RT300 generates currents that could cause electrocution if used improperly.
2. Safety of a pulse width greater than 1000 usec has not be established in patients less than 22
years of age.
3. RT300 is a medical device prescribed by a physician. RT300 should only be used by the
patient(s) for whom it is prescribed as it could cause harm otherwise.
4. If directed by a clinician, blood pressure and heart rate should be monitored during the therapy
session.
During therapy, if your patient’s blood pressure or heart rate reaches a level that is unsafe or if the
patient feels faint, light-headed or nauseous, stop the therapy session immediately. If these
symptoms do not return to normal, take appropriate medical action.
5. Stimulation should not be applied:
•on the side of the neck at the angle of the jaw (where you typically measure your pulse
over the carotid arteries) - it could cause a carotid sinus reflex, a rapid drop in blood
pressure and heart rate;
•over the neck or mouth - severe spasm of the laryngeal and pharyngeal muscles may
occur and the contractions may be strong enough to impede airflow or even block it
completely;
•across the chest (trans-thoracically) - artificial electrical current flow near the heart may
cause cardiac arrhythmia;
•to the head (trans-cerebrally) - artificial electrical current flow near the brain could have
unpredictable and dangerous effects;

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•directly on the eyes;
•over swollen, infected, or inflamed areas or skin eruptions, e.g. phlebitis,
thrombophlebitis, varicose veins, etc; and finally,
•over, or in proximity to, cancerous lesions.
6. Electrode placement and stimulation settings should be in accordance with the guidelines of
the prescribing clinician.
7. Simultaneous connection of a patient to high-frequency surgical medical electrical equipment
and RT300 with its SAGE Smart Therapy Controller may result in burns to the patient and
possible damage to the stimulator.
8. Operation of RT300 and its SAGE Smart Therapy Controller within approximately three feet
(one meter) of shortwave or microwave therapy medical electrical equipment may produce
instability in the controller output.
9. RT300 and its SAGE Smart Therapy Controller should be kept out of the reach of children,
pets, and pests. Children should only use RT300 under adult supervision. Never leave
RT300 unattended when children are present.
10. RT300 and its SAGE Smart Therapy Controller should be used only with leads and electrodes
that are provided by Restorative Therapies Inc and are in good condition.
11. Using electrodes that have current densities exceeding 2mA/cm
2
may require special attention
by the operator.
12. The long-term effects of chronic electrical stimulation are unknown.
13. Some medical conditions can be aggravated by physical activity. If the patient’s condition
worsens during or after a therapy session, appropriate medical attention may be required.
14. Interconnection of this equipment to other equipment not described in the instructions for use
could be unsafe.
15. Use of accessories, detachable parts, and materials not described in the instructions for use
could be unsafe.
16. The patient should always wear shoes, preferably rubber-soled athletic-type shoes, and long
socks to protect feet and ankles. Secure shoes and shoelaces with the Velcro straps when
using RT300 leg system.
17. When using RT300 for arm therapy, continuous assistance must always be available
because it may not be possible for the patient to stop the therapy if it is necessary to do so.
1.3 Precautions
Certain conditions or factors may increase the risk or discomfort associated with RT300 use or
decrease its effectiveness. However, the benefits may outweigh the potential drawbacks.
All of the following temporary or chronic considerations may require therapy modifications and/or
careful monitoring during therapy.
In all cases, guidelines for undertaking kinetic exercise should be considered
1
.
1.3.1 Nervous system/neurological considerations
Many cardiovascular parameters are regulated by the autonomic nervous system. While some of
the considerations below may appear to be cardiovascular, the underlying cause is a temporary or
chronic dysfunction of the autonomic nervous system. As such, they are included in this section on
nervous system considerations. Autonomic dysfunction is not uncommon in patients with spinal
cord injury (SCI).
1
American College of Sports Medicine, Guidelines for Graded Exercise Testing and Exercise Prescription, 4th Edition.
Lea & Febriger, 1991

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1.3.1.1 Autonomic dysreflexia
Autonomic dysreflexia is a potentially dangerous complication sometimes associated with SCI at
or above the T6 level. It is characterized by a sudden increase in blood pressure above safe
levels.
Symptoms can vary among individuals. Common signs of autonomic dysreflexia include severe
headache, a feeling of anxiety, profuse sweating above the level of injury, goose bumps
(piloerection) below the level of injury, dry and pale skin below the level of injury, blurred vision,
nasal congestion and abnormalities in cardiac rhythm.
Autonomic dysreflexia is typically triggered by noxious or unpleasant stimuli. The most common
trigger is irritation of the bladder or colon. It can also be triggered by electrical stimulation.
The likelihood of autonomic dysreflexia is reduced if the patient empties bladder and bowels before
beginning an RT300 therapy session. RT300 should NOT be used on a patient with a bladder
infection or fever.
Pay careful attention for any symptoms of autonomic dysreflexia that occur during a therapy
program session. Autonomic dysreflexia can occur at any time even if the patient has not
experienced it before or recently.
The vital signs display and the alarms from the pulse oximeter are not a substitute for careful
monitoring for any signs of autonomic dysreflexia or other health related issues.
Common signs of autonomic dysreflexia 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.
1.3.1.2 Orthostatic hypotension
Orthostatic hypotension is a form of low blood pressure that occurs when a person stands up from
a sitting or lying position. Many people occasionally experience it, feeling dizzy for a few seconds
to a few minutes.
1.3.1.3 Thermal Dysregulation
Patients with SCI may experience dysfunction of body temperature regulation (thermal
dysregulation). The impact of thermal dysregulation or overheating can be reduced by:
•exercising in an environment where temperature and humidity are controlled,
•staying hydrated, and
•limiting the duration and intensity of exercise in hot or cold environments.
1.3.1.4 Spasticity
Spasticity is generally not prohibitive to RT300 use. If a patient experiences spasticity, he/she may
benefit from a stretching program prior to therapy. Therapy program settings may require
modification to reduce the probability of spasm.
In the long-term, FES therapy often reduces spasticity despite increasing muscle strength.
1.3.1.5 Dysesthetic pain syndrome
Dysesthetic pain syndrome in SCI is characterized by a burning, aching and/or tingling sensation
below the level of injury. Electrical stimulation may aggravate symptoms of dysesthetic pain.

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1.3.1.6 Epilepsy
If a patient has suspected or diagnosed epilepsy, careful monitoring is required. Depending on the
severity, the patient may require a modified therapy or therapy may be prohibited.
1.3.1.7 Denervated muscles
Denervated muscles may not contract in response to stimulation.
1.3.2 Skeletal system
1.3.2.1 Heterotopic ossification/limited range of motion
Heterotopic ossification (the presence of bone in soft tissue where bone does not normally exist) is
not uncommon in SCI, musculoskeletal trauma or central nervous system injury. Associated limited
range of motion may be accommodated with appropriate positioning in the seated position.
a. At least100 degrees of hip and knee flexion is recommended for leg therapy without the
need for special positioning.
b. 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.
1.3.2.2 Fractures, dislocations and surgery
Fractures, dislocations, and surgery including but not limited to the following should be considered
before beginning RT300 therapy:
1.3.2.3 Mechanical implants
Plates, pins, screws, and other hardware must have been implanted at least three months prior to
RT300 use involving the effected limbs or joints.
1.3.2.4 Osteoporosis
Severe osteoporosis with increased risk of fractures requires a clinician’s modifications to therapy.
1.3.2.5 Spondylolisthesis
Spondylolisthesis (the forward movement of a vertebra out of position and onto the bone below it)
most often occurs with age but is also present in some cases of osteoporosis, arthritis or bone
disease and is not uncommon with SCI injuries. Depending on the severity, the patient may
require a modified therapy or therapy may be prohibited.
1.3.3 Wounds, infections, or fever
Pressure sores or open wounds in the area of treatment should heal before using RT300.
Compromised skin integrity of any type or an infection in the area of electrode placement can be
affected by electrodes/stimulation.
In addition, a urinary tract infection or high fever could increase the probability of autonomic
dysreflexia.
•acute hip replacement,
•hip fracture,
•upper or lower limb stress fractures or
•hip or knee dislocation or subluxation.

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1.3.4 Implanted devices or recent surgical procedures
Implanted stimulators such as vagus nerve, phrenic, cardiac, cochlear or diaphragmatic stimulators
may interfere with or be affected by upper extremity FES.
ANY other type of implanted device could also interfere with or be affected by RT300 use.
Any recent surgical procedure whose healing process could be disrupted by muscle contraction
should be evaluated.
1.3.5 Cardiovascular and respiratory considerations
The following circulatory or cardiovascular conditions should be evaluated by a clinician before a
patient begins RT300 therapy:
•suspected or diagnosed heart problems,
•high blood pressure or high heart rate, or
•tendency to hemorrhage following acute trauma or fracture.
Respiratory complications should be evaluated.
1.3.6 Cancer
If the patient has cancer, please consult the attending oncologist prior to RT300 use.
1.3.7 Menstruation
Caution should be used when applying electrical stimulation to the menstruating uterus.
1.3.8 Skin sensitivity to electrical stimulation
It is not uncommon to have some redness in the area of electrode placement during and/or after
therapy.
You can minimize the sensation of irritation or burning by not using electrodes more often than
recommended by their manufacturer and by not using an electrode or adhesive gel that has
expired or is visibly altered in condition.
Having ensured that the electrodes and adhesive gel are in good condition, if your patient still feels
an irritation at the site of the electrode, you can move it to a new location or try using a sensitive-
skin electrode.
If symptoms persist, therapy may be contraindicated.
1.3.9 Prolonged period of RT300 disuse
If a patient has not used RT300 for a prolonged period (e.g. a few months), please re-evaluate
therapy goals and therapy programs relative to the patient’s current condition.
1.3.10 Prolonged exposure
If the patient experiences contact injuries such as skin irritation from applied parts or accessories
due to prolonged exposure, stop using RT300 and re-evaluate therapy programs.
1.4 Upper extremity therapy for children
Torus fractures, also known as buckle fractures or incomplete fractures, are common in children.
They occur when a child’s bone, which is softer than an adult’s, buckles or bends back upon itself
without breaking the other side of the bone. Torus fractures have been reported in children during

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upper extremity therapy. To reduce the chance of wrist injury of this kind during RT300 arm
therapy, ensure that:
•the child’s wrists are well supported;
•the child always uses the hand, wrist and arm adaptations recommended by the
attending clinician; and
•the child remains seated facing straight ahead toward the SAGE tablet and avoids any
twisting motion in his/her forearm and wrist.
If the child complains of wrist pain or if you notice any swelling in the wrist during or after upper
extremity therapy, discontinue therapy immediately and re-evaluate therapy programs.
2 RT300 PATIENT ASSESSMENT FOR SUITABILITY
2.1 General considerations
In addition to careful consideration of the previously delineated contraindications, warnings, and
precautions, the following should be true for your patient to receive RT300 FES therapy.
•Patients should be at least two weeks post injury and at least 1 week post-spine surgery.
•Patients should demonstrate blood pressure control, e.g. be capable of 20 minutes in a
standing frame with no complications
2.2 RT300 range of motion (ROM) evaluation
2.2.1 Leg ROM
Photograph Description Pass/Fail
Hip and knee flexion:
Ensure there is appropriate hip and knee flexion
by lifting the leg so that the thigh is raised and the
hip and knee are flexed.
This should be done easily without significant
force.
Left:______
Right:_____
Knee extension:
Ensure there is appropriate knee extension by
lifting the foot and leg off the ground so that the
knee extends. The thigh should remain on the
chair.
This should be done easily without significant
force.
Left:______
Right:_____