Graham Field GF-TX5EMS User Manual

Electrical Neuromuscular
Stimulation
(EMS), Digital
Model GF-TX5EMS
Operation Manual
Read this manual before operating your GF-TX5EMS.
Save this manual for future use.
www.grahamfield.com
GF-TX5EMS-INS-LAB-RevC11
CONTENTS
GENERAL DESCRIPTION ................................................................................................... 3
WHAT IS EMS? INDICATIONS AND CONTRAINDICATIONS SAFETY
ABOUT THE DEVICE.......................................................................................................... 7
EXPLANATION OF KEY / KNOB CONTROL FUNCTIONS ATTACHING THE LEAD WIRES ELECTRODE SELECTION AND CARE TIPS FOR SKIN CARE CONNECTING THE DEVICE BATTERY INFORMATION CARING FOR YOUR DEVICE TROUBLESHOOTING TECHNICAL SPECIFICATIONS LIMITED WARRANTY
MANUAL DE OPERACIÓN EN ESPAÑOL ............................................................................ 17
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GF Health Products, Inc. (“Graham-Field”) is not responsible for typographi­cal errors. Packaging, warranties, products and specifications are subject to change without notice.
Graham-Field and Grafco are registered trademarks of GF Health Products, Inc.
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GENERAL DESCRIPTION

EMS, Electrical Neuromuscular Stimulation (Electrical Myostimulation), is a battery-operated pulse generator that sends electrical impulses to electrodes attached to the body to stimulate motor nerves and cause contraction and relaxation of muscles. It has proven valuable as a method of pain therapy and is of great assistance to the experienced therapist.
With some indications, physicians / clinicians can prescribe EMS units to patients for their use at home.
This unit is a dual-channel digital stimulator for active treatment application, which has a Liquid Crystal Display indicating operation modes and output, as well as an 8-bit microcomputer for controlling the system.
The electronics of the unit create electric impulses; the intensity, duration, frequency per second and modulation of these impulses can be adjusted.

WHAT IS EMS?

An injured muscle usually experiences little if any movement. EMS therapy remedies this by using low voltages to stimulate motor nerves to cause invol­untary muscular contractions.
Like exercise, EMS helps strengthen the injured area, and has been found to effectively treat a variety of musculoskeletal and vascular conditions. Com­mon candidates for EMS therapy are patients recovering from orthopedic surgery, muscle strains or tears, or athletes who have undergone cartilage or tendon repair. EMS is non-invasive and does not use pharmaceuticals.

INDICATIONS AND CONTRAINDICATIONS

Read the operation manual before using this EMS device. Federal law (USA) restricts this device to sale by or on the order of a physi-
cian. Observe your physician’s / clinician’s precise instructions and allow them to
show you where to apply the electrodes. For a successful therapy, the correct application of the electrodes is an important factor. Carefully write down the settings your physician / clinician recommends.
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Indications
Relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Contraindications
WARNING: This device should not be used by patients with cardiac demand
pacemakers.

SAFETY

Always follow basic safety precautions, including the following:
WARNING: Indicates a potential hazard situation or unsafe practice that, if not
avoided, could result in death or serious personal injury.
CAUTION: Indicates a potential hazard or unsafe practice that, if not avoided,
could result in minor or moderate personal injury.
s NOTICE: Indicates a potential hazard or unsafe practice that, if not avoided,
could result in product / property damage.
Warnings
WARNING: This device does not have AAP/APG protection.
Explosion hazard is possible if used in the presence of explosives, flammable
materials or flammable anesthetics.
WARNING: The long-term effects of chronic electrical stimulation are un-
known.
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WARNING: Do not place electrodes over the carotid sinus nerves, particularly
in patients with a known sensitivity to the carotid sinus reflex.
WARNING: Do not place electrodes over the neck or mouth. This may result in
spasms of the laryngeal and pharyngeal muscles, and the contraction may be strong enough to close the airway or cause difficulty in breathing.
WARNING: Do not apply stimulation transthoracically, because the introduction
of electrical current into the heart may cause cardiac arrhythmia. WARNING: Do not apply stimulation transcerebrally. WARNING: Do not apply stimulation over swollen, infected or inflamed areas or
skin eruptions; e.g. phlebitis, thrombophlebitis, varicose veins, etc. WARNING: Do not apply stimulation over or in proximity to cancerous lesions. WARNING: The safety of the device during pregnancy or delivery has not been
established. WARNING: Caution should be used for patients with suspected or diagnosed
heart problems. WARNING: Caution should be used when applying this device to patients sus-
pected of having heart disease. Further clinical data is needed to show if there
are adverse side effects on individuals with heart disease. WARNING: Caution should be used for patients with suspected or diagnosed
epilepsy. WARNING: Caution should be used in the presence of the following:
When there is a tendency to hemorrhage following acute trauma or fracture; Following recent surgical procedures when muscle contraction may disrupt the
healing process;
Over the menstruating or pregnant uterus; and Over areas of the skin which lack normal sensation.
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WARNING: Electrode placement and stimulation settings should be based on
the guidance of the prescribing practitioner. WARNING: Keep this device out of the reach of children. WARNING: Use this device only with the leads and electrodes recommended
for use by GF Health Products, Inc. WARNING: Do not use this device while driving, operating machinery, or dur-
ing any activity in which involuntary muscle contractions may put the user at
undue risk of injury. WARNING: EMS devices should be used only under the continued supervision
of a physician / clinician.
Precautions / Adverse Reactions
CAUTION: Some patients may experience skin irritation or hypersensitivity due
to the electrical stimulation or electrical conductive medium. Using an alter-
nate conductive medium or alternate electrode placement can usually reduce
the irritation. Consult your physician / clinician before using an alternative
conductive medium or electrode placement. CAUTION: Isolated cases of skin irritation may occur at the site of electrode
placement following long-term application. CAUTION: If skin irritation occurs EMS treatment should be stopped and elec-
trodes removed until the cause of the irritation can be determined. CAUTION: Effectiveness is highly dependent upon patient selection of a doctor
qualified in the management of pain patients. CAUTION: If the device treatment becomes ineffective or unpleasant, stimula-
tion should be discontinued until reevaluation by a physician / clinician. CAUTION: Always turn the device OFF before applying or removing electrodes.
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ABOUT THE DEVICE

This device is a battery-operated device that includes two controllable output channels. This device creates electrical impulses whose intensity, duration, and modulation can be altered. The device controls are easy to use and the slide cover protects accidental changes in settings.
System Components
Your device will include the following components or accessories:
EMS Unit
Carrying case
Lead wires
9-Volt battery
Operation Manual
Electrodes
Device Controls
Ch1 ON/OFF and Intensity Control Knob
Ch2 ON/OFF and Intensity Control Knob
LCD Panel
Key Control (Push Buttons)
Slide Cover
Slide Cover
This cover located on the front of the unit conceals the controls for DOWN, MODE, SET, and UP. Press the top portion of the cover and pull down in order to open the cover.
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EXPLANATION OF KEY / KNOB CONTROL FUNCTIONS

DOWN Key This key decreases the setting
MODE Key
SET Key
UP Key This key increases the setting
Ch1 / Ch2 Knobs
of treatment parameters. *
*Decrease by pressing the DOWN key: The width can be adjusted by 10μ/step. The rate can be adjusted in 1Hz~20Hz by 1Hz/step, 20Hz~150Hz by 5Hz/step. The cycle on/ramp/off time can be adjusted by 1 second/step.
This key selects Timer Mode, Stimulation Mode, Pulse Width Mode, Pulse Rate Mode, or Cycle On/Ramp/Off Time
This key switches between the different settings within Timer Mode and Stimulation Mode.
of treatment parameters. *
*Increase by pressing the UP key: The width can be adjusted by 10μs/step. The rate can be adjusted in 1Hz~20Hz by 1Hz/step, 20Hz~150Hz by 5Hz/step. The cycle on/ramp/off time can be adjusted by 1 second/step.
Channel 1 and Channel 2 Intensity Control Knobs
This key regulates the number of pulse width, pulse rate, and cycle on/ramp/off time.
This key changes the treatment parameter. Each time the MODE key is pressed, the next parameter will display. The selected treatment parameter in the current mode will ash.
Each time the SET key is pressed, the parameter will change to the next setting within the parameter. The selected setting will ash. When the desired setting is ashing, press the MODE key to conrm the choice.
This key regulates the number of pulse width, pulse rate, and cycle on/ramp/off time.
These knobs control the strength of the stimulation and also function as ON / OFF controls.
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ATTACHING THE LEAD WIRES

WARNING: Ensure the device is OFF before connecting the lead wires. WARNING: Never insert the lead wire plug into an AC power supply socket.
Personal injury and damage to the EMS unit could occur.
s NOTICE: Use care when you plug and unplug the wires. Pulling on the lead wire
instead of its insulated connector may cause wire breakage.
The lead wires provided with the device insert into the ports located on the top of the unit. If only one lead will be used, plug it into the channel 1 port. After connecting the wires to the unit, attach each wire to an electrode.
Lead wires provided with the device are compliant with mandatory compli­ance standards set forth by the FDA.
ELECTRODE SELECTION AND CARE Using Electrodes
Use the electrodes as prescribed. Follow application procedures outlined in electrode packaging to maintain stimulation and prevent skin irritation. The electrode packaging provides instructions for care, maintenance, and proper storage of electrodes.

TIPS FOR SKIN CARE

Good skin preparation is important for effective and comfortable use of your EMS device.
Always clean the electrode site with mild soap and water solution, rinse well, and dry thoroughly prior to any electrode application.
Any excess hair should be clipped, not shaved, to ensure good electrode contact with the skin.
If a skin treatment or preparation is recommended by your physician / clinician, apply the skin treatment as recommended, let dry, and apply electrodes as directed. Following these recommendations will both re­duce the chance of skin irritation and extend the life of your electrodes.
Avoid excessive stretching of the skin when applying electrodes. Proper
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application is best accomplished by applying the electrode, then smooth­ly pressing it in place from the center outward.
When removing electrodes, always remove by pulling in the direction of hair growth.
It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes.
CONNECTING THE DEVICE Inserting the Battery
Turn the device to the OFF position before inserting or removing the battery. When inserting the battery, ensure the battery polarity (+ and –) markings match the markings on the device.
Preparing the Skin
Prepare the skin as previously described and according to the instructions provided with your electrodes. Before attaching the electrodes, identify the area that your physician / clinician has recommended for electrode place­ment.
1. Connect the Lead Wires to the electrodes: Connect the lead wires to the electrodes before applying the electrodes to the skin.
CAUTION: Ensure both intensity controls for Channel 1 and 2 are turned to the
“OFF” Position (counterclockwise) before applying the electrodes.
2. Place Electrodes on the Skin: Place the electrodes on the skin as recom­mended by your physician / clinician.
3. Insert Lead Wire Connector into the Device: Plug end of lead wire into the channel output port (jack) to be used; push the plug in as far as it will go.
4. Select Treatment Settings: Ensure your unit is still set to the proper set­tings recommended by your physician / clinician.
5. Adjusting Channel Intensity Control: Locate the intensity control knob (Channel 1 or 2) at the top of the unit. Slowly turn the intensity control knob clockwise until the stimulation is at the level recommended by your physician / clinician. (If you don’t feel anything, turn the knob OFF then
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