Transcutaneous Electrical Nerve Stimulator
TENS 212
Instruction Manual
Read before using
TABLE OF CONTENTS
GENERAL DESCRIPTION 1
SYSTEM COMPONENTS 1
WARRANTY 1
INDICATIONS AND CONTRAINDICA TIONS 2
WA RNINGS AND PRECAUTIONS 2
DANGER 3
ABOUT THE DEVICE 3
THE DEVICE CONTROLS 4
ATTACHING THE LEAD WIRES 5
ELECTRODE SELECTION AND CARE 5
TIPS FOR SKIN CARE 5
CONNECTING THE DEVICE 6
BATTERY INFORMATION 6
CHANGING THE BATTERY 7
THE TENS 212 7
TROUBLESHOOTING 7
TECHNICAL SPECIFICATIONS 8
Procedure for Setting the Compliance Meter (Special For
Clinician)
9
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GENERAL DESCRIPTION
Transcutaneous Neuromuscular Electrical Stimulation (TENS) has proven its high value
as a method of pain therapy and is a great help to the experienced clinician. With some
indications, medical practitioners can prescribe a unit to patients for the use at home.
The TENS 212 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 a microprocessor for controlling the system.
The electronics of the unit create electric impulses: the intensity, pulse duration, pulse
frequency and modulation of these impulses can be adjusted by a button or a knob.
SYSTEM COMPONENTS
Your device includes the following components or accessories:
z Unit
z Carrying case
z Lead wires / Electrodes (ME 2120)
z 9-volt battery
z Instruction Manual
WARRANTY
The TENS 212 is warranted against defects in materials and workmanship for a period
of one year from date of purchase. During the applicable warranty period Mettler
Electronics Corp. will, at its discretion, either repair or replace the Product without
charge. Cables, electrodes, the case and battery are not covered under this warranty.
For service under this warranty, the Product must be returned by the buyer within the
applicable warranty period to Mettler Electronics Corp. Shipping charges to and from
Mettler Electronics Corp. under this warranty must be paid by the buyer. The
buyer must also include a copy of the sales receipt or other proof of the date of
purchase. If the Product is returned without proof of the date of purchase, it will
be serviced as an out–of–warranty product at Mettler Electronics Corp.’s
prevailing service rates.
Alteration, misuse, or neglect of the Product voids this warranty. Except as
specifically set forth above, Mettler Electronics Corp. makes no warranties,
express or implied, including without limitation any implied warranty of
merchantability or fitness for a particular purpose, with respect to the Product. If
any implied warranties apply as a matter of law, they are limited in duration to one
year.
Mettler Electronics Corp. shall not be liable for any indirect, special,
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consequential or incidental damages resulting from any defect in or use of the
Product.
Any legal action brought by the buyer relating to this warranty must be commenced
within one year from the date any claim arises and must be brought only in the state or
federal courts located in Orange County, California.
Some states do not allow limitations on how long an implied warranty lasts, or the
exclusion or limitation of incidental or consequential damages, so the above limitations
or exclusions may not apply to the buyer. This warranty gives the buyer specific legal
rights, and the buyer may also have other rights which vary from state to state.
INDICA TIONS AND CONTRAINDICATIONS
Read the operation manual before using the device.
Federal law (USA) restricts the sale of this device to, or on the order of a physician,
dentist, veterinarian or any other practitioner licensed by law of the state in which he/she
practices. Observe your practitioner’s precise instructions and let him/her show you
where to apply the electrodes. For a successful therapy, the correct application of
electrodes is an important factor. Carefully write down the settings your medical
practitioner recommended.
Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable
pain.
Contraindications
z Any electrode placement that applies current to the carotid sinus (neck) region.
z Patients with implanted electronic devices (for example, a pacemaker) or metallic
implants should not undertake.
z Any electrode placement that causes current to flow transcerebrally (through the
head). The use of this unit whenever pain symptoms are undiagnosed, until
etiology is determined.
z Do not use TENS whenever pain syndromes are undiagnosed, until etiology is
established.
WA RNINGS A ND PRECAUTIONS
Warnings
z The device must be kept out of the reach of children.
z The safety of this device for use during pregnancy or delivery has not been
established.
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z Do not place electrodes on front of the throat. This may result in spasms of the
laryngeal and pharyngeal muscles.
z Do not place the electrodes over the carotid nerve.
z The device is not effective for pain of central origin (headaches).
z The device may interfere with electronic monitoring equipment (such as ECG
monitors and ECG alarms).
z Electrodes should not be placed over the eyes, in the mouth, or internally.
z These devices have no curative value.
z TENS devices should be used only under the continued supervision of a licensed
medical practitioner.
z TENS is a symptomatic treatment and as such suppresses the sensation of pain
which would otherwise serve as a protective mechanism.
Precautions/adverse Reactions
z Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application.
z Stimulation should be stopped and electrodes removed until the cause of the
irritation can be determined.
z Effectiveness is highly dependent upon patient selection by a person qualified in
the management of pain patients.
z If the device treatment becomes ineffective or unpleasant, stimulation should be
discontinued until reevaluation by a medical practitioner.
z Always turn the device off before applying or removing electrodes.
z Skin irritation and electrode burns are potential adverse reactions.
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.
ABOUT THE DEVICE
Your device offers 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 and the cover prevents accidental
changes in the settings during treatment.
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THE DEVICE CONTROLS
Panel cover
A cover conceals the controls for Mode, Time, Width▲▼, Rate▲▼. Press the topside
of the cover and pull down in order to open the cover.
Intensity
The intensity knobs are 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 three modes
are Burst (B), Continuous (C) and Modulation (M).
TIME
Treatment Time of device can be pre-selected or set with the Time key. There are three
programs with fixed durations 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 on.
30 min: 15, 30 min symbols on.
60 min: 15, 30 and 60 min symbols on.
Continuous: 15 and 30 min symbols on continuously and the 60 min symbol flashes.
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.
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ATTACHING THE LEAD WIRES
The lead wires provided with the device insert into the jack sockets located on top of the
unit. Hold the insulated portion of the lead wire and push it into one of the jacks. After
connecting the wires to the stimulator, attach each pin connector to an electrode.
The lead wires provided with the device are compliant with mandatory compliance
standards as set forth by the FDA.
Note: Be careful when you plug and unplug the lead wires. Pulling on the lead
wire instead of its insulated connectors may permanently damage the lead wire.
Caution: Never insert the plug of the lead wire into an AC power supply socket.
ELECTRODE SELECTION AND CARE
Your medical 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.
To avoid high current density, be sure to use electrodes that are no smaller than those
provided with the TENS 212.
TIPS FOR SKIN CARE
Good skin care is important for comfortable use of your device.
z Always clean the electrode site with mild soap and water, rinse well, and blot dry
thoroughly prior to applying the electrode.
z Any excess hair should be clipped, not shaved, to ensure good electrode contact
with the skin.
z You may choose to use a skin treatment or preparation that is recommended by
your medical practitioner. Apply, let dry, and apply electrode as directed. This will
both reduce the chance of skin irritation and extend the life of your electrodes.
z 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.
z When removing electrodes, always remove by pulling in the direction of hair
growth.
z Do not use the electrode wire to remove the electrode from the skin. Peel it up
from one of the edges of the electrode.
z It may be helpful to rub skin lotion on electrode placement area when not wearing
electrodes.
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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 medical
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 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
medical practitioner.
6. Adjusting Channel Intensity Control
Locate the intensity control knobs 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. Repeat the
same process for Channel 2, if appropriate.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation intensity to a comfortable level. Cease stimulation and contact your
medical practitioner if problems persist.
BATTERY INFORMATION
A 9-volt disposable battery is provided with your unit. When the low-battery indicator
appears, the battery has become too weak to power the unit and will need to be
replaced. At this point, the unit will shut off until a fresh battery is inserted.
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CHANGING THE BATTERY
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 THE TENS 212
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 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 occurs, 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 5
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.
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TECHNICAL SPECIFICATIONS
Channel: Dual, isolated between channels
Pulse intensity: Adjustable 0-80 mA peak into 500 Ω load each channel,
constant current
Pulse Rate: 1Hz-160 Hz (adjustable), 1Hz/step (1-20 Hz), 5Hz/step
(20-160 Hz)
Pulse Width: 50 μs – 260 μs (adjustable), 10 μs / step
Patient Compliance meter: Shows the treatment times in hours.
Timer: 15, 30, 60 minutes and continuous mode
LCD: Shows modes, pulse rate, pulse width, timer, CH1/CH2.
Function Modes:
B: Cycle Bursts, 2 Bursts / sec, 9pulses/Burst, 100 Hz, width is adjustable.
C: Continuous mode. Pulse rate, pulse width and intensity are adjustable.
M: Modulated Width. Pulse width is automatically varied in an interval of 6 seconds. The
modulation range of pulse width is from setting value to 35% less than the control
setting value, then returns to the setting value. Rate, width and intensity are fully
adjustable.
Wave form: Asymmetrical Bi-phasic square pulse.
Voltage: 0-110 Volts (Open Circuit).
Max charge per pulse: 21 micro-coulombs
Power Source: 9-Volt Battery.
Dimensions: 108 mm(H) × 61.5 mm(W) × 25 mm(T).
Weight: 140 grams (battery included).
All electrical specifications are ±10% 500 Ω load.
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Procedure for Setting the Compliance Meter (Special For Clinician)
When you want to see the compliance meter or reset it, follow the instructions below.
1. To enter the Compliance mode: First, switch the device off. Then, hold
down the “Time” key as you turn on the TENS 212. If the “hr” symbol appears on the
display, the device is now in doctor mode. If the “hr” symbol does not appear, turn the
machine off and try again.
2. To see Compliance meter value: After you enter the Compliance mode, the patient
compliance meter appears on the LCD with the ‘hr’ symbol.
3. To reset the compliance meter value: When you want to reset the compliance
meter value for a new treatment cycle, follow the steps listed below:
When you are in the Compliance mode, first press and release the ‘MODE’ key. Then
press and release the ‘Rate ▼’ key. This will reset the treatment time hours to zero.
4. To exit the Compliance mode: Turn off the unit. The next time you turn it on it will be in
the normal treatment mode.
5. User mode: Just turn on the unit without holding any keys, then you are in the
treatment mode.
Printed in Taiwan IR9-54
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