QUATTRO EMS GM380E User manual

Powered Muscle Stimulator (EMS)
Read before using
QUATTRO EMS
Model: GM380E (4CH EMS)
FDA 510k
Operation Manual

TABLE CONTENTS
GENERAL DESCRIPTION 1
SYSTEM COMPONENTS 1
WARRANTY 1
INDICATIONS AND CONTRAINDICATIONS 1
WARNINGS AND PRECAUTIONS 2
ABOUT THE DEVICE 3
THE DEVICE CONTROLS 4
DANGER 4
ATTACHING THE LEAD WIRES 4
ELECTRODE SELECTION AND CARE 5
TIPS FOR SKIN CARE 5
CONNECTING THE DEVICE 5
BATTERY INFORMATION 6
CHANGING THE BATTERY 6
9-VOLT DC ADAPTOR 7
CLEANING FOR YOUR DEVICE 7
TROUBLESHOOTING 7
TECHNICAL SPECIFICATIONS 8

GENERAL DESCRIPTION
Electric stimulation has proven its high value as a method of pain therapy and is a
great help to the experienced therapist.
With some indications, physicians can prescribe a unit to patients for the use at
home.
This series of device is the combination of two units with dual-Channel electric
stimulator for active treatment application, which is equipped with a Liquid Crystal
Display indicating operation modes and output as well as an 8-bit micro computer
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 through
the button or knob.
SYSTEM COMPONENTS
Your device may include the following components or accessories:
zUnit
zCarrying case
zLead wires / Electrodes
z6 x UM-3/AA size1.5V batteries.
zAdaptor
zOperation Manual
WARRANTY
This device carries a one-year warranty from the date of purchase. The warranty
applies to the device and necessary parts and labor relating thereto. The
distributor reserves the right to replace or repair the unit at their discretion.
The warranty does not apply to electrode, batteries, lead wires, carrying case,
damage resulting from failure to follow the operating instructions, accidents, abuse,
alterations or disassembly by unauthorized individuals.
INDICATIONS AND CONTRAINDICATIONS
Read the operation manual before using the device.
Federal law (USA) restricts this device for sale by or on the order of a physician.
Observe your physician’s precise instructions and let him 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
recommended.
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Indications for use
zRelaxation of muscle spasms.
zPrevention or retardation of disuse atrophy.
zIncreasing local blood circulation. Muscle re-education.
zMaintaining or increasing range if motion.
zMuscle re-education.
zImmediate post-surgical stimulation of calf muscle to prevent venous
thrombosis.
Contraindications
Powered muscle stimulators should not be used on patients with cardiac demand
pacemakers.
WARNINGS AND PRECAUTIONS
Warnings
zThe long-term of chronic electrical stimulation are unknown.
zStimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.
zStimulation should not be applied over the 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.
zStimulation should not be applied trans-thoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
zStimulation should not be applied transthoracically.
zStimulation should not be applied over swollen, infected, or inflamed areas or
skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
zStimulation should not be applied over, or in proximity to, cancerous lesions.
zStimulation should not be applied trans-cerebrally (across the head).
zEMS devices should be used only under the continued supervision of a
physician.
Precautions/adverse Reactions
zSafety of powered muscle stimulators for use during pregnancy has not been
established.
zCaution should be used for patients with suspected or diagnosed heart
problems.
zCaution should be used for patients with suspected or diagnosed epilepsy.
zCaution should be used in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma of
fracture;
b. Following recent surgical procedures when muscle contraction may
disrupt the healing process;
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c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation.
zSome patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can
usually be reduced by using an alternate conductive medium, or alternate
electrode placement.
zElectrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
zPowered muscle stimulators should be kept out of the reach of children.
zPower muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
Skin irritation and burns beneath the electrodes have been reported with the use of
powered muscle stimulators.
ABOUT THE DEVICE
Your device offers two controllable output channels for each stimulation unit. This
device creates electrical impulses whose amplitude, duration, and modulation can
be altered with the controls or buttons.
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THE DEVICE CONTROLS
Intensity
The intensity knobs are located on the front of the unit for the strength adjustment
of the stimulation and also function as ON/OFF controls.
Mode
The Mode key is used to select / set the type of treatment utilized. The available
stimulation modes for each unit are as indicated in the following table:
Identification Function as Available mode
E EMS
S (Synchronous), C (constant),
A (Alternation)
TIME
Treatment Time of device can be pre-select / set with Time key. There are seven
programs fixed duration of 5, 10, 15, 20, 30, 45, 60 minutes and continue. Press
the key until engaged in position desired.
5 min : 1/4 circle icon flash.
10 min : 2/4 circle icons flash.
15 min : 3/4 circle icons flash.
20 min : 4/4 circle icons flash.
30 min : 2/4 circle icons light on.
45 min : 3/4 circle icons light on
60 min : 4/4 circle icons light on.
Continue : the timer icon become empty.
SET/ENT
The SET/ENT keys are used to select the type of treatment utilized. The type of
treatment utilized includes cycle On time, On Ramp time, cycle Off time and Pulse
Rate. The selected parameter will flash during adjust.
▲▼
The ▲▼ keys regulate the number of On, Ramp, Off and Pulse Rate value.
DANGER
The device does not have AP/APG protection. Explosion hazard is possible if used
in the presence of explosives, flammable materials or flammable anesthetics.
Caution should be used when applying the device to patients suspected of having
heart disease. Further clinical data is needed to show if there are adverse side
effects on those with heart disease.
ATTACHING THE LEAD WIRES
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The lead wires provided with the device insert into the jack sockets located on rear
of the unit. Holding the insulated portion of the connector, push the plug end of the
wire into one of the jacks. After connecting the wires to the stimulator, attach each
wire to an electrode.
Lead wires provided with the device are compliant with mandatory compliance
standards set for the by FDA.
Note: Use carefully when you plug and unplug the wires. Pulling on the lead wire
instead of its insulated connector may cause wire breakage.
Caution: Never insert the plug of the lead wire into an AC power supply socket.
ELECTRODE SELECTION AND CARE
Your physician/practitioner should decide which type of electrode is best for your
condition. Follow application procedures outlined in electrode packaging to
maintain stimulation and prevent skin irritation. The electrode packaging will
provide instruction for care, maintenance and proper storage of your electrodes.
Be sure to use the electrodes provided by the manufacturer and/or the similar FDA
legally marketed electrode in particular the same cross section area.
TIPS FOR SKIN CARE
Good skin care is important for comfortable use of your device.
zAlways clean the electrode site with mild soap and water solution, rinse well,
and blot dry thoroughly prior to any electrode application.
zAny excess hair should be clipped, not shoved, to ensure good electrode
contact with the skin.
zYou may choose to use a skin treatment or preparation that is recommended
by your physician. Apply, let dry, and apply electrode as directed. This will
both reduce the chance of skin irritation and extend the life of your
electrodes.
zAvoid excessive stretching of the skin when applying electrodes, this is best
accomplished by applying the electrode and smoothly pressing it in place
from the center outward.
zWhen removing electrodes, always remove by pulling in the direction of hair
growth.
zIt may be helpful to rub skin lotion on electrode placement area when
wearing electrodes.
CONNECTING THE DEVICE
1. Prepare the Skin
Prepare the skin as previously discussed and according to instructions provided
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with your electrodes. Before attaching the electrodes, identify the area in which
your physician/practitioner has recommended for electrode placement.
2. Connect lead wires to the electrodes
Connect the lead wires to the electrodes before applying the electrodes to the skin.
Note: Be sure all intensity controls for every Channel 1 and 2 of each unit are
turned to the “OFF” position.
3. Place Electrodes on Skin
Place the electrodes on the skin as recommended by your clinician.
4. Insert Lead Wire Connector to device
Plug end of lead wire into the channel output receptacle to be used, pushing plug
in as far as it will go.
5. Select Treatment Settings
Check and be sure your unit is still set to the proper settings recommended by
your physician/practitioner.
6. Adjusting Channel Intensity Control
Locate the intensity control knob at the front of the unit. Slowly turn the intensity
control knob for the channels to be used clockwise until you reach the intensity
recommended by your medical professional. Always start with the lowest step and
increase slowly.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation amplitude to a comfortable level or cease stimulation and contact your
physician/practitioner if problems persist.
BATTERY INFORMATION
The 6 x 1.5-volt UM-3/AA size disposable batteries are provided with your unit.
When the low battery mark light on the LCD the battery has become too weak to
power the unit and it is time to change the battery. At this point, the unit will shut off
until a fresh battery is inserted.
CHANGING THE BATTERIES
When the low battery mark light is on the LCD panel, the batteries should be
replaced with the fresh batteries.
1. Remove the battery cover by pressing this cover and sliding down until it is
completely removed from the unit this will reveal the battery compartment.
2. Remove the discharged batteries from the device.
3. Place new batteries in compartment. Note the proper polarity alignment
indicated on the battery and the compartment.
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9-Volt DC Adaptor
Because the current consumption is large for the device, it is recommended to use
the 9V DC adaptor. Plug the DC plug into the DC jack of the unit, and plug the
adaptor into your 110V wall outlet. Please be sure you are using the correct
polarity of DC plug.
CLEANING FOR YOUR DEVICE
Your device may be cleaned by wiping gently with a damp cloth moistened with
mild soap and water. Never immerse the device in water or other liquids.
Wipe lead wires with a damp cloth as above if they become soiled.
To properly store the device an extended period of time, remove the battery from
the unit. Put the unit and accessories in the carrying case and store in a cool dry
location.
TROUBLESHOOTING
If the device does not function properly:
1. Make sure the battery is properly installed or replace battery. Be sure to
observe proper polarity markings when replacing the battery. If the low battery
mark light is on the LCD pane when the unit is turned on, replace the battery
and check again.
2. If the intensity has been adjusted and there is no stimulation, check that the
leas wires are properly connected and the electrodes are in place. If the unit
appears to be functioning and no stimulation, the lead wires or electrodes may
need to be replaced.
3. If the battery appears to be charged and the unit is not functioning, turn both
intensity Control Knobs of each unit to the OFF position (counter
clockwise) for about 7 sec. Then gradually turn the intensity Control Knob
clockwise until stimulation is felt. If the device is still not working, turn off your
device and contact your distributor.
Note : For any problem, please contact your distributor. Do not try to repair
this device by yourself.
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TECHNICAL SPECIFICATIONS
Channel: Four, isolated between channels
Pulse amplitude: Adjustable 0-100mA peak into 500 Ωload each
channel, constant current
Pulse Rate: 1Hz-160Hz (adjustable), 1Hz/step
Pulse Width: 300µs fixed.
Software ramp up feature: Pulse width ramp up when change mode
Patient Compliance
counter:
Shows the treatment times. Account by hours.
Patient Lock System: To prevent the user from changing any fixed
parameters set by the physician.
Timer: 5,10,15,20,30,45,60 minutes or Continue selectable
LCD: Shows modes, pulse rate, pulse width, timer,
CH1/CH2 of each unit.
ON Ramp: Adjustable 1-8 seconds. 1sec/step.
Cycle ON Time: Adjustable 1-30 seconds. 1 sec/step.
Cycle OFF Time: Adjustable 1-30 seconds. 1 sec/step.
Function Modes:
S: Synchronous.
C: Constant.
A: Alternation.
Wave Form: Asymmetrical Bi-Phasic square pulse.
Max charge per pulse: 30 micro-coulombs maximum
Voltage: 0-110 Volt (Open Circuit).
Power Source: 6 pieces of 1.5V UM-3/AA size batteries or 9-Volt adaptor
Dimension: 287 x 224 x 79 mm
Weight: Approx. 1250g (without batteries)
All electrical specifications are ±10% 500Ωload.
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Remark:
PrintedinTaiwan OP-380E-Q01
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