High Voltage Pulsed Galvanic Stimulator
Read before using
Model: GM323HV
ULTRA-G FDA 510k
Digital Galvanic
CE
Operation Manual 0434
TABLE CONTENTS
GENERAL DESCRIPTION
SYSTEM COMPONENTS
WARRANTY
INDICATIONS AND CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ABOUT THE DEVICE
THE DEVICE CONTROLS
DANGER
ATTACHING THE LEAD WIRES
ELECTRODE SELECTION AND CARE
TIPS FOR SKIN CARE
CONNECTING THE DEVICE
POWER SUPPLY INFORMATION
CHANGING THE BATTERY
CLEANING FOR YOUR DEVICE
TROUBLESHOOTING
TECHNICAL SPECIFICATIONS
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GENERAL DESCRIPTION
Electric myostimulation 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 unit to patients for the use at home.
The unit is a 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.
The High Voltage Pulsed Galvanic Stimulator has a“ twin peaked monophasic
waveform with fixed interpulse Interval of 100 + s”. Each pulse is much shorter in
duration (5 s) and can achieve much higher voltage than conventional stimulator.
SYSTEM COMPONENTS
Your device may include the following components or accessories:
e Unit
o Carrying case
o Lead wires / Electrodes
9 9-volt battery or 9V DC adaptor
© Operation 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 electrodes, battery, 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 to sale by or on the order of a physician. Observe
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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.
Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable
pain.
Contraindications
o Any electrode placement that applies current to the carotid sinus (neck) region.
o Patients with implanted electronic devices (for example, a pacemaker) or metallic
implants should not undertake.
o Any electrode placement that causes current to flow transcerebrally. (through the
head) The use of unit whenever pain symptoms are undiagnosed, unit etiology is
determined.
e The use of stimulator whenever pain syndromes are undiagnosed, until etiology
is established.
WARNINGS AND PRECAUTIONS
A Warnings
The device must be kept out of reach of children.
e The safety of device for use during pregnancy or delivery has not been
established.
© Do not place electrodes on front of the throat. This may result is spasms of the
laryngeal and pharyngeal muscles.
© Do not place the electrodes over the carotid nerve.
© The device is not effective for pain of central origin (headaches).
e The device may interfere with electronic monitoring equipment (such as ECG
monitors and ECG alarms).
o Electrodes should not be placed over the eyes, in the mouth, or internally.
o These devices have no curative value.
o This devices should be used only under the continued supervision of a physician.
o The device is a symptomatic treatment and as such suppresses the sensation of
pain which would otherwise serve as a protective mechanism.
A Precautions/adverse Reactions
o Isolated cases of skin irritation may occur at the site of electrode placement
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following long-term application.
e Stimulation should be stopped and electrodes HET until the cause of the
irritation can be determined.
e Effectiveness is highly dependent upon patient selection by a person qualified in
the management of pain patients.
© If the device treatment becomes ineffective or unpleasant, stimulation should be
discontinued until reevaluation by a physician/clinician.
© Always turn the device off before applying or removing electrodes.
© Skin irritation and electrode burns are potential adverse reactions.
ABOUT THE DEVICE
Your device offers one controllable output channels. This device creates electrical
impulses whose amplitude, rate and modulation can be altered with the controls or
buttons. The device controls are very easy to use and the slide cover protects
accidental changes in settings.
CHZ2 Output Receptacle
ON/OFF and Amplitude Control
© > CH1 Output Receptacle
LCD Panel
KEY Control
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Slide Cover | 7
THE DEVICE CONTROLS
Panel cover
A cover conceals the controls for Mode, Rate A W. Press the topside of the cover and
pull down in order to open the cover.
Intensity
The intensity knob is located on the top 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 two modes are
Continuous (C) and Alternation (A).
RATE AV
The pulse Rate key regulates the number of pulse per second. By pressing the À you
can adjusting the frequency increasing. By pressing the Y you can adjusting the
frequency decreasing.
DANGER
The device does not have AAP/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
The lead wires provided with the device insert into the jack sockets located on top 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.
There are two kinds of lead wires. One is the normal lead wire which has twin wires (red
and black polar); used for the output receptacle of Channel 1. The other one is single
wire (red polar); used for the output receptacle of Channel 2 as Active 2. If user only
use the C' (Continuous) mode, use the twin wires (red and black polar) into the output
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receptacle of Channel 1. If use the ‘A mode, use both wires for both output receptacles.
twin wires (red and black polar) single wire (red polar) for Active 2 only.
Note: The single wire (red) is only for the active 2 output receptacle (Channel 2)
and it must be combined with the twin wires of the output receptacle of Channel
1.
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.
Note: The small size of electrode are for the active electrode ( red color), the large size
of electrodes are for the dispersive electrode (black color)
TIPS FOR SKIN CARE
Good skin care is important for comfortable use of your device.
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© Always clean the electrode site with mild soap and water solution, rinse well, and
blot dry thoroughly prior to any electrode application,
® Any excess hair should be clipped, not shaved, to ensure good electrode contact
with the skin.
e You 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.
© Avoid 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.
o When removing electrodes, always remove by pulling in the direction of hair
growth.
9 It may be helpful to rub skin lotion on electrode placement area when not wearing
electrodes.
CONNECTING THE DEVICE
1. Prepare the Skin
Prepare the skin as previously discussed and according to instructions provided 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 the intensity control is 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. Adjusting Channel Intensity Control
Locate the intensity control knob at the top of the unit. Slowly turn the intensity control
knob for Channel 1 clockwise until you reach the intensity recommended by your
medical professional. Always start with the lowest step and increase slowly.
If the stimulation level is uncomfortable or become uncomfortable, reduce the
stimulation amplitude to a comfortable level or cease stimulation and contact
your physician/practitioner if problems persist.
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POWER SUPPLY INFORMATION
Battery Information
A 9-volt disposable battery is 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.
9-Volt DC Adaptor
The 9-volt DC adaptor is another power source. Plug the DC plug into the DC jack of the
unit, and plug the adaptor into your 110V wall outlet.
Note: Be sure to use the DC Adaptor provided by the manufacturer.
CHANGING THE BATTERY
When the low battery mark light is on the LCD panel, the battery should be replaced
with a fresh battery.
1. Remove the panel cover by pressing the top and sliding down until is completely
removed from the unit this will reveal the battery compartment.
2. Remove the discharged battery from the device.
3. Place new battery in compartment. Note the proper polarity alignment indicated on
the battery and the compartment.
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 for 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 lead
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 the
intensity Control Knob to the OFF position (counter clockwise). Then gradually turn
the intensity Control Knob clockwise until stimulation is felt. If device still is not
working, turn the unit off and contact your distributor.
4. There is the short circuit protection for the 9 Volts DC adaptor supplied by
manufacturer. Output power will be cut off automatically when the output is being
shorted. In order to recover the Adaptor after the cut-off, please let the Adaptor rest
(unplug it) for more than one minute before re-plug the adaptor.
If there is any other problem, please consult or return the device to your
distributor. Don’t try to repair a defective device.
TECHNICAL SPECIFICATIONS
Channel: Single channel. Two active outputs and one dispersive
return. Where active 1 and dispersive located on the
output of CH1, the active 2 located on the output of CH2.
Output Voltage: Adjustable, 0 - 350 Volts maximum (500 ohm load)
Pulse Rate: 1Hz-120Hz (adjustable), 1Hz/step
Pulse Duration: ous
Interpulse Interval: 10048
Software Ramp Up Change mode or A mode, the output will reset to zero
then ramp up to its original setting intensity. It protect user
avoid sudden surge.
LCD: Shows modes, pulse rate and low battery.
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Function Modes:
C: Continuous mode. Constant stimulation via active 1 and dispersive electrodes of
output receptacle of Channel 1.
A: Alternating mode. Alternates stimulation every 5 seconds between active 1 and
active 2 outputs.
Wave form: Twin peaked monophasic waveform with fixed interpulse
Interval of 100 u S.
Power Source: 9-Volt Battery or 9 Volts DC adaptor.
Dimensions: 108mm(H) x61.75mm(W) x25mm(T).
Weight: Approx. 140grams (battery included).
Tolerance: +20% of intensity; +10% of other parameters.
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Printed in Taiwan
OP-323HV-K01
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