Apex Digital Digi-Stim GM320T SD TENS User manual

Model: GM320T SD TENS

“BF” symbol, indicate this product is according to the degree of
protecting against electric shock for type BF equipment.
Consult operating instructions for use.
Attention – Observe proper Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an appropriate collection point for the recy-
cling of electrical and electronic equipment. For more detailed information about
the recycling of this product, please contact your local city o󰘲ce, household waste
disposal service or the retail store where you purchased this product.
Authorised representative in the European Community.
Manufacturer.
SYMBOLS
CE mark and noti󰘰ed body registration number, the Annex II article 3 of
EC directive 93/42/EEC have been met.

CONTENTS
GENERAL DESCRIPTION................................................................... 1
SYSTEM COMPONENTS ................................................................... 1
WARRANTY .............................................................................. 2
INDICATIONS AND CONTRAINDICATIONS ..................................................... 2
WARNINGS AND PRECAUTIONS ............................................................ 4
ABOUT THE DEVICE....................................................................... 6
THE DEVICE CONTROLS................................................................... 7
DANGER ................................................................................ 8
ATTACHING THE LEAD WIRES .............................................................. 9
ELECTRODE SELECTION AND CARE......................................................... 9
TIPS FOR SKIN CARE......................................................................10
CONNECTING THE DEVICE.................................................................11
BATTERY INFORMATION ...................................................................12
CHANGING THE BATTERY..................................................................13
CLEANING FOR YOUR DEVICE..............................................................13
TROUBLESHOOTING ......................................................................14
TECHNICAL SPECIFICATIONS...............................................................15

1
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.
GENERAL DESCRIPTION
SYSTEM COMPONENTS
Your device may include the following components or accessories:
●Unit
●Carrying case
●Lead wires (LW01) / Electrodes (FA4040)
●9-volt battery
●Operation Manual

WARRANTY
INDICATIONS AND CONTRAINDICATIONS
This device carries a one-year warranty from the date of purchase. The warranty applies to the de-
vice 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, battery, lead wires, carrying case, damage resulting from
failure to follow the operating instructions, accidents, abuse, alterations or disassembly by unauthor-
ized individuals.
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 your phy-
sician’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 set-
tings your physician recommended.
2

Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Contraindications
●Any electrode placement that applies current to the carotid sinus (neck) region.
● Patients with implanted electronic devices (for example, a pacemaker) or metallic implants should
not undertake.
● Any electrode placement that causes current to 󰘱ow transcerebrally. (through the head) The use of
unit whenever pain symptoms are undiagnosed, unit etiology is determined.
● The use of TENS whenever pain syndromes are undiagnosed, until etiology is established.
3

4
Warnings
●The device must be kept out of reach of children.
●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 e󰘯ective for pain of central origin (headaches).
● The device may interfere with electronic monitoring equipment (such as ECG monitors and ECG
alarms).
●Electrodes should not be placed over the eyes, in the mouth, or internally.
●These devices have no curative value.
● TENS devices should be used only under the continued supervision of a physician.
● TENS is a symptomatic treatment and as such suppresses the sensation of pain which would
otherwise serve as a protective mechanism.
WARNINGS AND PRECAUTIONS

5
Precautions/adverse Reactions
● Isolated cases of skin irritation may occur at the site of electrode placement following long-term
application.
● Stimulation should be stopped and electrodes removed until the cause of the irritation can be de-
termined.
● E󰘯ectiveness is highly dependent upon patient selection by a person quali󰘰ed in the management
of pain patients.
● If the device treatment becomes ine󰘯ective or unpleasant, stimulation should be discontinued until
reevaluation by a physician/clinician.
● Always turn the device o󰘯 before applying or removing electrodes.
● Skin irritation and electrode burns are potential adverse reactions.

6
ABOUT THE DEVICE
Your device o󰘯ers two controllable output channels. This device creates electrical impulses whose
amplitude, duration, and modulation can be altered with the controls or buttons. The device controls
are very easy to use, the cap and slide cover protect accidental changes in settings.

7
Slide Cover
A cover conceals the controls for Mode, Time, Width▲▼, Rate▲▼. Press the front of the cover and pull
down in order to open the cover.
Intensity
The intensity knobs are located on the top of the unit under the cap 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 󰘰ve modes for SD TENS are
Burst (B), Continuous (C), Modulation (M), Strength-Duration and Rate modulation (SDR), Strength
Duration and Width modulation (SDW).
TIME
Treatment Time of device can be pre-select / set with Time key. There are three programs 󰘰xed dura-
tion of 15, 30 and 60 minutes and one program of continuous output. Press the key until engaged in
position desired.
15 min : 15 min symbol light on.
30 min : 15, 30 min symbols light on.
THE DEVICE CONTROLS

8
60 min : 15, 30 and 60 min symbols light on.
Continuous: 15 and 30 min symbols light on, and the 60 min symbol flashes.
To reset timer, turn both channels o󰘯. When you are ready to begin another treatment cycle (at least
rest for 7 seconds), turn the unit on as normal. The timer will be reset to its current setting.
WIDTH ▲▼
The pulse Width key regulates the pulse width for both channels.
RATE ▲▼
The pulse Rate key regulates the number of pulse per second for both channels.
DANGER
The device does not have AP/APG protection. Explosion hazard is possible if used in the presence of
explosives, 󰘱ammable materials or 󰘱ammable 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 e󰘯ects on those with heart disease.

9
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, and pushing 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 as set forth
by the 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.
ATTACHING THE LEAD WIRES
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 irrita-
tion. 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.

10
Good skin care is important for comfortable use of your device.
● 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.
●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 ap-
plying the electrode and 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.
TIPS FOR SKIN CARE

11
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 recommend-
ed 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 both intensity controls for Channel 1 and 2 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 set to the proper settings as recommended by your physician/practi-
tioner.
CONNECTING THE DEVICE

12
6. Adjusting Channel Intensity Control
Locate the intensity control knobs at the top of the unit under the cap. Open the cap 󰘰rst, 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. Repeat the same process
for Channel 2, if appropriate. Close the cap after intensity setting ok.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation amplitude to a
comfortable level. Cease stimulation and contact your physician/practitioner if problems persist.
BATTERY INFORMATION
A 9-volt disposable battery is provided with your unit. When the low-battery indicator appears, the bat-
tery has become too weak to power the unit and will need to be changed. At this point, the unit will shut
o󰘯 until a fresh battery is inserted.

13
When the low-battery indicator appears on the LCD panel, the battery should be replaced with a fresh
battery.
1. Remove the slide cover by pressing the top and sliding down until it 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 both the
battery and the compartment.
CLEANING FOR YOUR DEVICE
CHANGING THE BATTERY
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.

14
If the device does not function properly:
1. Make sure the battery is properly installed, or replace the battery. Be sure to observe proper
polarity markings when replacing the battery. If the low-battery indicator appears 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 occur, 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 to the OFF position (counter clockwise) for about 7 sec. 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.
If any other problems occur, please consult or return the device to your distributor.
Don’t try to repair a defective device.
TROUBLESHOOTING

15
TECHNICAL SPECIFICATIONS
Channel Dual, isolated between channels
Pulse intensity Adjustable 0-80mA peak into 500 Ω load each channel, constant current
Pulse Rate 1Hz-160Hz (adjustable), 1Hz/step (1-20Hz), 5Hz/step (20-160Hz)
Pulse Width
50μs - 260μs (adjustable), 10μs/step
Patient Compliance meter Shows the treatment times in hours
Patient Lock System Prevents the user from changing any xed parameters set by the physician or
licensed practitioner
Software Ramp Up By changing mode, the output will reset to zero then ramp up to its original
setting intensity
It will protect users from a sudden surge
Timer 15, 30, 60 minute and continuous mode selectable
LCD Shows modes, pulse rate, pulse width, timer, CH1/CH2

16
TENS
BCycle Bursts, 2Bursts/sec, 9pulses/Burst, 100Hz, width is adjustable.
CContinuous mode. Pulse rate, pulse width and intensity are full adjustable.
M
Modulated Width. Pulse width is automatically varied in an interval of 6 seconds. The modula-
tion range of pulse width is from setting value to 35% less than the control setting value. And
then returns to the setting value. Rate, width and intensity are fully adjustable.
SDR
Strength-Duration and Rate modulation. SDR consists of alternating modulated intensity (am-
plitude) and pulse rate so that one parameter is always increasing while the other is decreasing
and vice-versa. The stimulation intensity decreases 20% from the intensity control setting and
returns to the setting value; the pulse rate increase 45% from the modulated rate to the setting
value and return to the modulated rate. Total cycle time is 6 seconds. Rate, Width and Intensity
are full adjustable.
SDW
Strength-Duration and Width modulation. SDW consists of Alternating modulated intensity
(amplitude) and pulse width so that one parameter is always increasing while the other is de-
creasing and vice-versa. The stimulation intensity decreases 20% from the intensity control
setting and returns to the setting value; the pulse width increase 54% from the modulated width
to the setting value and return to the modulated width. Total cycle time is 6 seconds. Rate, width
and intensity are full adjustable.
Function Modes: