Empi Direct Tens User Manual

Supplied by EME Services Ltd

Transcutaneous Electrical Nerve Stimulator

for Pain Treatment

USER GUIDE

Direct TENS

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™

CONTENTS...

Quick Start Guide
General Information

Points to Note Before Use

1

2

............................................................................................................................................ Page 6

2 How does the Direct TENS™ Device function?

2.1 TENS Therapy Principle

............................................................................................................................................................ Page 10

................................................................................................................... Page 9

2.2 Description of the Programs and the Corresponding Indications

3 Preparation

3.1 Inserting Batteries

3.2 Applying Electrodes, Connecting Leadwires

3.3 Selection, Care and Placement of the Electrodes

4 Treatment

4.1 Starting Therapy

4.2 Ending Therapy

5 Special Direct TENS Functions

5.1 Therapy Timer

5.2 Factory Defaults Settings

6 What to do, if

7 Care, Storage, Battery Replacement, Disposal

8 Ordering Information, Specications

8.1 Information related to electromagnetic compatibility (EMC)

.................................................................................................................................................................................. Page 14

...................................................................................................................................................................... Page 14

................................................................................................................... Page 14

.......................................................................................................... Page 15

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........................................................................... Page 11

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QUICK START GUIDE...

1. Insert batteries

+

3

-

-

+

2. Attach belt clip and close battery compartment

3. Connect the electrodes to the leadwire

4. Apply the electrodes.
The electrode placement depends on the indication, see also chapter 2.2 / page 11

5. Connect the electrode leadwire to the device

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QUICK START GUIDE...

6. Switch the therapy unit on

7. Select a program (only possible when intensity = 0)
The program depends on the indication to treat, see also chapter 2.2 / page 11

4

OR

8. Set intensity for selected channel

9. After approx. 10 seconds the keys are automatically locked to prevent the treatment parameters from

being changed inadvertently. To unlock the keys, press either key (channel 1 or 2).

10. To terminate the treatment simply turn o the device with the ON/OFF key. When the therapy timer is
activated, the stimulator switches automatically o at the end of the programmed interval.

Note: The Belt Clip can be attached or removed as required. You can nd the procedure to attach/remove the

belt clip on page 14, chapter 3.1.

Direct TENS

0473

Storage temperature: from-20˚C to 45˚C
Max. relative humidity: 75%
Atmospheric pressure: from 700hPa to 1060hPa

Manufacturer

DJO - LLC

0473

EC REP

EU Authorized Representative

MDSS GmbH

Supplied by EME Services Ltd

™

GENERAL INFORMATION...

• The product Direct TENS™ bears the CE marking CE-0473 (Notied Body: AMTAC Certication Services Limited)
showing that it complies with the Council Directive 93/42/EEC as amended concerning medical devices and fulls
the essential requirements of Annex I of this directive. It has an internal power source and is classied as IIa
equipment (MDD).

• The device has a type BF applied part.

• The device fulls the requirements of the standard EN 60601-1 “Medical electrical equipment, Part 1: General
requirements for safety” as well as the immunity requirements of the standard EN 60601-1-2 “Electromagnetic
compatibility - medical electrical equipment”.

• This manual is an integral part of the device and should be kept near the device at all times. Close observance of the
information given in this manual is a prerequisite for using the device as intended and for correct operation to
ensure user’s safety. Please note that information pertinent to several chapters is given only once.

Therefore, carefully read the manual once in its entirety.

5

• Using the device for purposes other than those described in this manual is not permitted.

• The safety information given in this manual is classied as follows:

Warning

Indicates a hazard. If not avoided, the hazard can

result in death or serious injury.

Indicates a potential hazard. If not avoided, the

hazard may result in minor injury and/or

Caution

product/property damage.

• No part of this manual may be reproduced without written permission from DJO.

• Key to symbols used on the equipment

Caution, consult accompanying documents

Patient part type BF- Body oating

Device complies with the Council Directive 93/42/EEC
about medical devices, tested and approved by AMTAC
Certication Services Limited

Manufacturer
DJO, LLC
1430 Decision Street
920181 Vista, CA
USA
Phone: [phone]
Fax: [phone]

Do not dispose with unsorted domestic waste

MDSS GmbH
Schigraben 41
30175 Hannover

EC REP

Germany
Phone: [phone]
Fax: [phone]

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1. POINTS TO NOTE BEFORE USE...

6

Intended Use

Direct TENS™ is a transcutaneous electrical nerve
stimulator. Transcutaneous electrical nerve stimulation
(TENS) uses electrical pulses that are delivered
through the skin to the cutaneous (outer) and
aerent (deeper) nerves to alleviate pain. Contrary to
medication and cream used on the skin, there are no
known side eects resulting from TENS therapy.
Use Direct TENS™ only as described in this manual.
Other uses of the stimulator are not permitted.

Indications

• Direct TENS™ can be used to alleviate dierent types
of acute and chronic pain such as

• Joint pain (e.g. knee, hip arthrosis)

• Chronic pain originating in the spine

• Degenerative diseases of the musculoskeletal
system

• Tension headache

Contraindications

Do not use Direct TENS™ in the following situations:

• If you have an implanted demand pacemaker,
intracardiac debrillator or other active implants

• Undiagnosed pain until the cause has been
ascertained

• Epilepsy

• During pregnancy (unless approved by your
referring gynaecologist)

Treatment should never be applied near the area of
an implant, such as cochlear, pacemakers, skeletal or
electrical.

Do not apply stimulation in the vicinity of metal. Remove
jewellery, body piercings, buckles or any other removable
metallic product or device in the area of stimulation.

Do not attempt to place electrodes on any part of the
body not directly visible without assistance.

• Radiating pain (e.g. back pain, cervicobrachial
syndrome)

• Amputation stump/phantom limb pain

• Pain from rheumatic diseases

Do not stimulate at the front or side of the neck to avoid
a drop in blood pressure. Furthermore it is not permitted
to attach electrodes to the head.

This device should not be used for symptomatic local
pain relief unless diagnosis is established or unless a pain
syndrome has been diagnosed.

Biocompatibility

Those parts of the Direct TENS™ that come into contact
with the user when the device is used as intended, are
designed to full the biocompatibility requirements of
the applicable standards.

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7

Warnings

• Magnetic and electrical elds are capable of
interfering with the proper performance of the
device. Do not use the Direct TENS™ device in
the vicinity of equipment that emits high levels
of electromagnetic radiation, such as X-ray
equipment, MRI devices, radio systems and
mobile telephones. These devices may aect the
Direct TENS™ output power. Keep the device away
from such equipment and verify its performance
before use (section “Treatment”). Not for use in
presence of shortwave therapy device.

• Disconnect the Direct TENS™ stimulation
electrodes before using electrosurgical
equipment or debrillators. Otherwise skin burns
may be caused below the electrodes and the
Direct TENS™ device may be destroyed.

• Avoid the simultaneous use of Direct TENS™ and
electronic patient monitoring systems. Direct
TENS™ may interfere with the proper functioning
of these systems, compromising the monitoring
quality.

• Do not use more than one stimulator at a time.

• Avoid stimulation in the vicinity of your heart
unless approved by your physician.

• Keep the stimulator out of reach of children.

• Do not apply electrodes around the throat area or
the anterior neck as this could cause severe muscle
spasms resulting in closure of your airway, diculty
in breathing, or adverse eects on heart rhythm or
blood pressure.

• Do not use the stimulator when in the bath, shower
or humid environment
(sauna, hydrotherapy, pools, etc.).

• Do not use the stimulator while driving, operating
machinery, or during any activity in which electrical
stimulation can put you at risk of injury

• Stimulation should not be carried out over swollen,
infected, and inamed areas or skin eruptions, e.g.,
phlebitis, thrombophlebitis, varicose veins, etc.

• Stimulation should not be carried out over, or in
proximity to, cancerous lesions.

• Never carry out the rst 5 minutes of any stimulation
session standing. Make sure you are seated or
lying down. In rare instances, people of a nervous
disposition may experience a vasovagal reaction.
This is a psychological response triggered by fear of
the procedure.

• Never connect the stimulation cables to an external
power source due to risk of electric shock.

• If you are in the care of a physician, consult your
physician before using this device.

• If you have had medical or physical treatment for
your pain, consult your physician before
using this device.

• If your pain does not improve, worsens, or continues
for more than ve days, stop using the device and
consult your physician.

• Sudden temperature changes can cause
condensation to build up inside the stimulator. To
prevent this, allow it to reach ambient temperature
before use.

• Never use the electrodes contra-laterally, i.e. do not use
two poles connected to the same channel on opposite
segments of the body.

• Stimulate with precaution while treating angina
pectoris and the thoracic region on patients with
cardiac arrhythmia.

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Caution

User’s hazard and comfort

• Inspect the stimulator and its accessories for integrity before use.
If you detect signs of damage, do not use the stimulator.

• Use only original accessories (electrodes, cables).

• Do not use the stimulator during sleep.

• Do not open the battery compartment while the stimulator is operating.

• Use caution if you have a tendency to bleed internally, such as following an injury or fracture.

• Consult your physician prior to using the device after a recent surgical procedure,
because stimulation may disrupt the healing process.

• Always switch o the stimulator before disconnecting any stimulation cables during a session.

• TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a
protective mechanism.
TENS devices have no curative value.

8

• Use caution if stimulation is carried out over areas of skin that lack normal sensation.

• Attach the electrodes in such a way that their entire surface is in contact with the skin.

Equipment damage

• Remove the batteries from the Direct TENS™ device, if it is not used for a prolonged period of time
(more than approx. 3 months).

• Liquids or foreign matter (soil, metal, etc.) must not enter the stimulator. If liquids have entered the stimulator or if it
was accidentally immersed in liquid, stop using it and return it to DJO for inspection.

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2. HOW DOES THE DIRECT TENS™ DEVICE FUNCTION...

Via electrodes attached to the skin, Direct TENS™ sends electrical pulses to the nerves. This will block the pain impulses.
Four electrodes – two for each channel – can be connected to the device. Pain relief is most ecient during
stimulation, but the eect can last after the treatment. Additionally, the TENS treatment increases the blood
circulation. You can use Direct TENS™ at any time for pain relief and muscle relaxation. Each therapy session should last
30 minutes minimum and can be continued for several hours.

This is where you connect the electrode lead wires.

9

This key are used to increase
the current and thus the
intensity of stimulation:
Increase the intensity very
carefully!

This key are used to
decrease the intensity
and to unlock the
locked keys during
operation.

These keys are used
to select one of the 13
programs.

This button is used to switch
the stimulator on and o. If
no stimulation is started for
approximately 5 minutes,
the stimulator automatically
switches o to save batteries.

These are the quick select keys for
choosing an indication-related program.

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2.1. TENS therapy principle

Two pain theories play an important role in the application and parameter settings of the Direct TENS™ device:

• The Gate Control Theory by WALL and MELZACK (1965)

• The Endorphine Theory by ERIKSON and SJÖLUND (1979)

According to the Gate Control Theory, weak TENS impulses block the pain impulses travelling to the
brain (sensor stimulation).
ERIKSON and SJÖLUND found that strong TENS impulses increase the release of internal substances (e.g. endorphins)
that also alleviate pain (motor stimulation).

Theory Gate Control Theory Endorphin Theory
Principle Via sensory nerves Via motor nerves
Intensity Low, light tingling High, just bearable

Impulse Width

Frequency

1

1

Short, e.g. 100 µs Long, e.g. 250 µs
100 Hz 2-10Hz

Muscle Contraction No Yes
Onset Pain Relief Quickly Slowly (20-60 minutes)
Duration of Pain Relief Short (5-15 minutes) Long (30 minutes-12 hours or longer)
Treatment Duration Permanent 30-60 minutes, 3-5 times/day

10

1

For easier operation, intensity and pulse width are combined in Direct TENS™.

(low intensity = short pulse width, high intensity = long pulse width)

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2.2. DESCRIPTION OF THE PROGRAMS AND THE CORRESPONDING INDICATIONS...

11

Program Stimulation Frequency (Hz) General

Indications

1 1 impulse every 2 seconds 0.5 Kaada TENS

(similar to
acupuncture)

2 Double pulse at 20 Hz

(pulse separation 3 ms)

20 Cervical spine

syndrome

Tense muscles

3 High frequency, 1000 Hz 1000 Acute, strong back

pain (lumbar spine)

4 Bi-modal Channel 1 =

Tension headache
100Hz
Channel 2 = 4Hz

Neck / back pain

Radiating pain

5 Burst with alternating work and

rest phases of 3 and 2 seconds
respectively

Work = 100Hz
Rest = 0Hz

Tense muscles

Amputation stump

/phantom limp

pain

Advantages

Ideal for sensitive people

Supports acupuncture
treatment

Muscle relaxation
by double pulses

Strong analgesia

Brief, very intensive TENS
treatment

Simultaneous treatment
with high and low
frequency

In 2-channel mode,
channel 1 stimulation is
superimposed on the low
frequency stimulation in
channel 2

Easily tolerable stimulation
for chronic pain conditions

Sensory as well as motor
stimulation

6 Similar to program 5, but

channels 1 and 2 alternating
and longer work/rest times, 6
seconds respectively

7 Intensity decreases 40% in 0.5

second intervals

Herpes zoster

Reex sympathetic

dystrophy (RSD)
Work = 100Hz

See program 5 Similar to program 5,
Rest = 0Hz

100 Lumbar back pain

Joint pain

but channels 1 and 2
alternating

Similar to massage

Eects both on the sensory
and on the motor level

Avoids habituation

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12

Program Stimulation Frequency (Hz) General

Advantages

Indications

8 Random modulation of intensity

and frequency (down to 50%
of set intensity and frequency
modulation between 8 dierent

Random
modulation

Chronic pain
resisting therapy

Avoids habituation

Sensory as well as
motor stimulation

frequencies, 2-150 Hz)

9 Continuous 2 – 150 Standard TENS Fast pain relief in acute pain

conditions

Fast acceptance of therapy

Dierent programmable
frequencies, e.g.

100 Hz = Standard
2 Hz = Similar to
acupuncture

10 Burst with alternating work and

rest phases of 2 seconds each

Work =
2 - 150 Hz

Long-term
treatment

Classic burst

Pleasant form of stimulation
Rest =
0 Hz

Reduces muscle fatigue

Prolongs battery life

11 Mixed frequency Phase 1 =

2 - 150 Hz

Phase 2 = 50%
of work freq

Strong pain Pleasant stimulation also at

higher intensities

Permanent stimulation of

the deep aerent nerve

bers with modulated

muscle activation

12 Multi modulation 2 – 150 Chronic pain Avoids habituation

Simultaneous sensory and

motor stimulation

Fixed modulation pattern for

intensity and frequency

13 Simple modulated pulse

2 – 150 Chronic pain Avoids habituation

(SMP), intensity modulation
diametrically opposite to
frequency modulation according

Simultaneous sensory and

motor stimulation

to a xed 12-second cycle

Intensity and frequency

modulation according to

xed pattern, but

diametrically opposed, i.e.,

when the intensity

increases, the frequency

decreases and vice versa.

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Frequency Selection for Programs 9 to 13

2 – 60 Hz 60 – 150 Hz

Preferred in the treatment of chronic pain Preferred in the treatment of acute pain

With the standard TENS programs 9 to 13, the frequency can be adapted manually.
Possible settings: 2, 10, 20, 40, 60, 100, 125, 150 Hz

Factory defaults for programs 9 to 12 is 100 Hz and 125 Hz for program 13.

Changing the frequency:

1. Turn on the device and select one of the programs 9 to 13

2. Simultaneously press the program selection keys and release them.

3. Using the intensity keys , choose the set frequency.

13

4. Press the two program selection keys again or switch the device o to save the settings.

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3. PREPARATION...

3.1. Inserting Batteries

• Adjust the belt clip until it points to the right at
a 90° angle. (Figure 3-1)

• Push the battery cover down and lift.
(Figure 3-2)

• Insert the batteries as shown in the illustration.
Observe the correct polarity,
see label in battery compartment. (Figure 3-3)

• Reinstall the battery cover and close the
compartment.

Notes:

• Use only new AA type batteries.

• You may or may not use the belt clip, as
preferred. Open the battery compartment. If
you wish to remove the clip, pull it out towards
the left. If you wish to attach the clip, push it
into the holder from the left. When you close
the battery compartment, the belt clip is
automatically secured onto the
device. (Figure 3-4)

• Dispose of the worn out batteries in
accordance with local and national regulations

14

Figure 3-1
Turning the belt clip

Figure 3-2
Opening the battery compartment

3.2. Applying Electrodes, Connecting Leadwires

• First connect the electrode leadwires to the electrodes
(Figure 3-5). (The colour of the electrode
connectors is irrelevant.)

• Peel the electrodes o their protective paper. Keep the
protective paper and the bag, because the electrodes
will be reattached to the protective paper after use and
stored in the bag (see also 3.3.2 “Care of the Electrodes”).

• Carefully apply the electrodes on the skin (see also 3.3.3
“Electrode Placement”).

• Connect the electrode leadwire(s) to the Direct TENS™
device (Figure 3-6).

Figure 3-3
Inserting the batteries

Figure 3-4
Removing/attaching the belt clip

Figure 3-5
Connecting the electrode
leadwire to the electrodes

Figure 3-6
Connecting the electrode
leadwire to the device

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3.3. Selection, Care and Placement of the Electrodes

3.3.1. Electrode Selection

Use large electrodes (e.g. 50 x 90 mm, to be purchased
separately) for large body areas (e.g. back, leg) and for
general conditions of pain.
Use small electrodes (e.g. 50 x 50 mm) for small body
areas (e.g. face, hand) and for deep, local pain.

3.3.2. Care of the Electrodes

When properly handled and maintained, the supplied
electrodes can be used 20 times or more.

Important for a long service life:

• Clean the skin application sites with mild soap
water before attaching the electrodes. After cleaning,
thoroughly rinse with water and dry the skin carefully.

• Dry electrodes with poor adhesion can be reconditioned
as follows: apply a small quantity of water to the
adhesive surface with your nger tip.

• If you face bad contact with the skin or repeated open
lead detection, change the electrodes.

• Remove electrodes by pulling on their edges.
Do not pull on the leadwire.

• After use, reattach the electrodes to their protective
paper. Store the electrodes in their bags.

• Store the electrodes in a refrigerator, if possible.
Do not store them in warm rooms.

• We recommend shaving skin sites where electrodes
will be applied, if very hairy. Shaving irritates the skin.
Therefore wait 24 hours after shaving before you attach
the electrodes. Then you may start therapy.

• Do not leave the electrodes attached to your skin for
a prolonged period of time. Remove the electrodes
after each use. Apply the electrodes on dierent sites to
avoid skin irritations. For the same reason clean the skin
thoroughly after treatment. If you observe skin
irritations, consult your physician and suspend therapy
until clarication.

15

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3.3.3. Electrode Placement

If your physician showed you the best application points,
we recommend that you use them.
Otherwise gures 3-7 to 3-11 show
possible electrode congurations.
Figures 3-12 to 3-21 show electrode congurations
for dierent indications. However, check that the
conguration is appropriate and adapt, if necessary.
Depending on the site and cause of the pain, electrodes
may be placed on acupuncture points or in specic
dermatomic areas.
In other situations we recommend applying the
electrodes around the center of the pain at a distance of 3
to 5 cm (where you feel the pain).

Notes:

• Concerning the choice of indication-specic programs,
please refer to the Notes in section 2.2.

• Before applying the electrodes, observe the care
instructions in section 3.3.2.

• If appropriate, you can also use only two
electrodes (one channel).

16

Caution

Failed stimulation, skin irritation, malfunction -

• Use only the original electrodes supplied with
the system and replacement electrodes
provided by DJO.

• Attach the electrodes on intact skin only, avoid
skin areas with reduced sensitivity.

• Ensure that good contact is achieved between
electrode and skin. Although the stimulator
switches o when the electrode-skin contact
resistance is too high, poor electrode
techniques may cause skin irritations
under the electrodes.

Figure 3-7 Bilateral placement
(e.g. cervical dysfunction)

Figure 3-8 Diagonal placement
(e.g. shoulder or knee)

Figure 3-9 Parallel placement (e.g.
on scarred tissue) Figure 3-10 Bracket position

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Figure 3-11 Electrode application in pain
conditions involving the shoulder and
shoulder blade

17

Figure 3-12 Electrode application on the
shoulder blade

Indications:

e.g. General pain in the shoulder
accompanied by headache

Figure 3-13 Electrode application on the
shoulder joint

Indications:

e.g. General pain in the shoulder, bursitis

Figure 3-15 Electrode application on the
cervical spine Picture to be replaced

Indications:

e.g. for conditions of pain in the muscles or
soft parts, see also Figure 3-15

Recommended electrode placement:

Parallel

Figure 3-14 Electrode application on the
cervical spine

Indications:

e.g. pain caused by intervertebral disk or
vertebral arch joint problems , cervical
spine syndrome, cervical syndrome, tension
headache, migraine

Recommended electrode placement:

Diagonal

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18

Figure 3-16 Electrode application on
the knee joint

Indications:

e.g. arthrosis of the knee joint (gonarthrosis),
generalized pain in the knee, TEP

Recommended electrode placement:

Attach electrodes above supercial skin nerves
or acupuncture points around the knee joint.
The electrode conguration may be parallel,
medial, lateral or crosswise above or
below the knee.

Figure 3-18 Electrode application
on the back

Indications:

Radicular (radiating) pain

Recommended electrode placement:

Channel 1 proximal and distal to the pain
area, channel 2 above the nerve.

Figure 3-17 Electrode application
on the back

Indications:

e.g. lumbar spine syndrome,
lumboischialgia, pseudoradicular back pain

Recommended electrode placement:

paraspinal, proximal and distal to the pain
area. Channels 1 and 2 diagonal

Figure 3-19 Electrode application
on the back

Indications:

Radicular (radiating) pain (alternative)

Recommended electrode placement:

Channel 1 proximal and distal to the pain
area, channel 2 above the nerve.

Figure 3-20 Electrode application for
phantom limb pain, version 1

Figure 3-21 Electrode application for
phantom limb pain, version 2

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4. TREATMENT...

19

Figure 4-1 Switching the stimulator on

Duration of the Stimulation

Selected program

4.1. Starting Therapy

• Switch the stimulator on.

Once switched on, the display will briey show the
software version. A functional test where all display
indicators appear for a short time is performed. The initial
screen appears next (Figure 4-2).
When the initial screen is displayed, the device has
successfully passed the functional test.
If the letter “E” is displayed instead of the initial screen, the
stimulator is defective and must be replaced. Do not use
this stimulator any more.

On the initial screen you will see:

- The remaining stimulation duration

- The intensity of the stimulation (indication of the
selected intensity level, adjustable in steps
of 0.5 from 0 to 60)

- The selected program

• Select the program either via the quick select keys or via
the program selection keys.

• Increase the stimulation intensity for a channel

Stimulation Intensty

Figure 4-2 Initial screen

(1 or 2) by pressing the corresponding key.

Increase the intensity with great care and in
small increments. Select a level which causes a
pleasant sensation that is felt clearly.

Additionally, icons may appear on the screen

The keys are locked (automatic function): To prevent inadvertent activation, the keys are
automatically locked 10 seconds after the current intensity has been set. The keys can be unlocked

with or by switching the device o.

The electric circuit is interrupted (see chapter 6 “What to do, if...)

Batteries need to be replaced. When you see this icon, replace the batteries as soon as possible.

Operation Information

• You can interrupt therapy at any time with the ON/OFF switch.

• If the stimulator is not used, it switches o automatically after approx. 5 minutes.

• When the therapy timer is activated, the device switches automatically o at the end of the
programmed interval. The remaining therapy time is always indicated on the display.

• The program can only be changed when the intensity in both channels is 0.

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4.2. Ending Therapy

The default setting of the Direct TENS™ device is
continuous operation. If you want to end the therapy,
switch o the device with the ON/OFF switch.
When the therapy timer is activated, the device switches
automatically o at the end of the programmed interval.
The remaining time is indicated at the top of the display.
Check that the Direct TENS™ stimulator is switched o
before you remove the electrodes.

• If the therapy timer is not activated, switch o the Direct
TENS™ stimulator with the ON/OFF switch.

• Remove the electrodes very carefully. Do not pull on the
leadwires, but on the electrode.

• Reattach the electrode to its protective paper. Be sure
to attach the electrode to the side marked “on”, not to
the side marked “no”.

20

• Disconnect the electrodes from the leadwire.

• Clean the skin with a mild soap solution.

• Electrodes no longer t for use can be disposed of with
the normal domestic waste.

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5. SPECIAL DIRECT TENS™ FUNCTIONS...

5.1. Therapy Timer

The Direct TENS™ stimulator comes with a therapy timer function. When the timer is activated, the remaining therapy
time appears on the display. When this interval has elapsed, the device switches o automatically.
You can set therapy times of:

• 1 to 59 minutes in 1-minute increments

• 1 to 24 hours in 30-minutes increments

• Continuous operation, displayed as CONT. (this is the default setting), the timer is not activated

Follow these steps to activate the timer:

• Press the quick select program key

low back/hip and hold it depressed.

21

• Then press the ON/OFF key to switch the device on.

• The display indicates “Time” and the currently set therapy time (default setting: CONT.).

• Press the intensity control keys for channel 2 to set the therapy time. With you select a longer time,

with , a shorter time. Go back to 00:00 to get the Continuous mode (CONT.).

• To save the timer settings, turn o the stimulator. When you turn the stimulator on again, the
timer setting you saved is displayed.

5.2 Factory Defaults Settings

• Hold the program selection key depressed.

• Then press the ON/OFF key to switch the device on.

• The display shows DATA 000 000 ashing.

• Next press the two intensity decrease keys simultaneously for channels 1 and 2

to reset the device to the factory defaults:

- All stored data will be deleted.

- The timer function is deactivated.

- The program lock is deactivated.

- The frequency for all programs is reset to the respective default value.

- Program 9 is selected.

- The initial screen is displayed.

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6. WHAT TO DO, IF...

...the stimulation feels unpleasant or dierent from previous sessions

• Check whether

- The device settings were changed.

- The electrodes are correctly placed and applied on the skin. Electrodes with poor adhesion must be replaced.

- The skin is irritated.

...the stimulation is weak or not felt

• Check whether

- The electrodes are properly applied to the skin. Electrodes with poor adhesion must be replaced.

- The battery replacement symbol is displayed and the batteries need to be replaced
(see the “Battery Replacement” section in chapter 7).

- The “electric circuit interrupted” icon is displayed. This icon appears when the resistance between electrode and skin
is too high. Reasons may be a poor electrode attachment or an interrupted electric circuit.
When the electric circuit is interrupted, the intensity drops to 0. In this case check whether the electrode leadwire
is correctly connected to the device and whether the electrodes are properly connected. If the problem persists, the
electrode leadwire is probably broken and must be replaced.

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...the letter “E” is displayed instead of the initial screen

In this case the device is defective and must not be used. Return the device to DJO for replacement.

...the device cannot be switched on

• Check whether

- The batteries are inserted

- The batteries are correctly inserted

- The batteries are charged.

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7. CARE, STORAGE, BATTERY REPLACEMENT, DISPOSAL...

Care, Maintenance

• Switch o the device before cleaning. Then clean it with a moist cloth. Liquids must not enter the device. If necessary,
apply a drop of dishwashing liquid to remove stubborn stains.

• Do not use abrasive substances or other domestic cleaning agents.

• To clean the leadwire, disconnect it from the device and wipe it down with a moist cloth.
Never immerse the leadwire in liquids.

• Direct TENS™ does not require regular maintenance.

Storage

• Always store the Direct TENS™ stimulator in its original pouch.

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• Keep the device and the pouch out of reach of children.

• Store the device in a cool and dry place. Do not expose the device to direct sunlight.

• Remove the batteries from the device, if it is not used for a prolonged period of time (more than approx. 3 months).

Battery Replacement

Use only Alkaline batteries 15 A LR6 size AA 1.5 Volt or NiMH rechargeable batteries size AA 1.2 Volt
(rechargeable batteries and charger not provided)

• Switch o the Direct TENS™ device.

• Turn the belt clip 90° to the right (see also section 3.1).

• Push the battery cover down, then up (see also section 3.1).

• Insert the batteries. Observe the correct polarity (see also section 3.1).

• Reinstall the battery cover and close the compartment.

• Dispose of the old batteries, observing the local regulations.

Disposal at the End of Its Service Life

The symbol indicates that the waste of electrical and electronic equipment must not be disposed as

unsorted domestic waste and must be collected separately. Please contact DJO for information about the possible
recycling of the product or comply with your local regulation.

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8. ORDERING INFORMATION, SPECIFICATIONS...

Ordering Information

Electrodes used up?
Questions about the product?
We at DJO would be happy to help!

To avoid wrong deliveries, please indicate the part
numbers when ordering products:

Part Number Product

42190 Electrodes, Square 5x5 cm Durastick, Wire, pkg. of 4 electrodes
42191 Electrodes, Rectangular 5x9 cm Durastick, Wire, pkg. of 4 electrodes
193068-100 Lead wire, 100cm (40 inches)

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To reorder, please contact:

DJO France
Centre Européen de Fret
64990 Mouguerre
France
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.DJOglobal.eu

8.1. Information related to electromagnetic
compatibility (EMC)

The Direct TENS™ is designed to be used in typical
domestic or clinical environments and approved
according to the EMC safety standard of EN 60601-1-2.

This device emits very low levels in the radio frequency
(RF) interval and is therefore not likely to cause any
interference with nearby electronic equipment (radios,
computers, telephones etc.).

The Direct TENS™ is designed to withstand foreseeable
disturbances originating from electrostatic discharges,
mains supply magnetic elds or radio frequency
transmitters (such as mobile telephones).

For more detailed information regarding electromagnetic
emission and immunity, please contact DJO.

Specications

Number of channels 2
Constant Voltage Up to a resistance of 1000

ohms

Output Intensity 0…60, adjustable in 0.5

steps

Maximum Output 40 mA @ 1000 ohms, 250

μs

Waveform Asymmetrical biphasic

square impulse

Frequency Range 0,5 – 1000 Hz
Impluse Duration Determined by intensity

setting, 0 – 250 μs

Power Supply 2 x 1.5 V AA disposable

batteries

or

2 x 1.2 V AA rechargeable
batteries

Current consumption

50 mA

for 1 channel, 200 µs
impulse duration, 100 Hz
and 40 V

Ambient conditions
(operation)

Temperature 10°C to 40°C
Relative humidity 30...75
%, no condensation
Atmospheric pressure 700
to 1060 hPa

Ambient conditions
(storage, transport)

Temperature 10°C to 40°C
Relative humidity 30...75
%, no condensation
Atmospheric pressure 500
to 1060 hPa

Dimensions (HxWxD) 110 x 70 x 30 mm
Weight 165 g (including batteries)

Direct TENS

Supplied by EME Services Ltd

™

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You have more questions?
Get in touch with us!

DJO, LLC
1430 Decision Street
92018 Vista CA
USA
Phone: [phone]
Fax: [phone]
www.DJOglobal.eu

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