cefar Direct TENS User manual

Transcutaneous Electrical Nerve Stimulator
for Pain Treatment
USER GUIDE
Direct TENS™

2
Direct TENS™
CONTENTS
Quick Start Guide ............................................................................................................................................................3
General Information........................................................................................................................................................5
Key to the Symbols ..........................................................................................................................................................6
1. Points to Note Before Use ..................................................................................................................................7
2. How Does the Direct TENS™ Device Function?....................................................................................... 11
2.1. TENS Therapy Principle .......................................................................................................................................12
2.2. Description of the Programs and the Corresponding Indications...................................................13
3. Preparation............................................................................................................................................................... 16
3.1. Inserting Batteries................................................................................................................................................. 16
3.2. Applying Electrodes, Connecting Leadwires............................................................................................. 16
3.3. Selection, Care and Placement of the Electrodes....................................................................................17
4. Treatment ..................................................................................................................................................................21
4.1. Starting Therapy .....................................................................................................................................................21
4.2. Ending Therapy ......................................................................................................................................................22
5. Special Direct TENS™ Functions.....................................................................................................................23
5.1. Therapy Timer.........................................................................................................................................................23
5.2. Factory Defaults Settings...................................................................................................................................23
6. What To Do, If........................................................................................................................................................ 24
7. Care, Storage, Battery Replacement, Disposal ........................................................................................25
8. Ordering Information, Specifications.......................................................................................................... 26
9. Electromagnetic Compatibility (EMC) Tables ..........................................................................................27

3
Direct TENS™
1. Insert batteries
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 13
5. Connect the electrode leadwire to the device
+
+
-
-
QUICK START GUIDE

4
Direct TENS™
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 13
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 find the procedure to attach/remove the
belt clip on page 16, chapter 3.1.
QUICK START GUIDE

5
Direct TENS™
• The product Direct TENS™ bears the CE marking CE-0473 (Notified Body: AMTAC Certification Services
Limited) showing that it complies with the Council Directive 93/42/EEC as amended concerning medical
devices and fulfils the essential requirements of Annex I of this directive. It has an internal power source
and is classified as IIa equipment (MDD).
• The device has a type BF applied part.
• The device fulfils 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.
• Using the device for purposes other than those described in this manual is not permitted.
• The safety information given in this manual is classified as follows:
• No part of this manual may be reproduced without written permission from DJO.
• Key to symbols used on the equipment
Warning
Indicates a hazard. If not avoided, the haz-
ard can result in death or serious injury.
Caution
Indicates a potential hazard. If not avoided,
the hazard may result in minor injury and/or
product/property damage.
GENERAL INFORMATION

6
Direct TENS™
REF Reference number, part number
Follow instruction for uses
Type BF applied parts
Council Directive 2012/19/EU concerning Waste Electrical and Electronic Equipment (WEEE)
requires not to dispose of WEEE as municipal waste. Contact your local distributor for
information of the unit and accessories
Keep the device dry
70C
(158F)
-40C
(-40F)
Minimum and maximum temperature indications to respect
This equipment complies with all requirements of the Medical Device Directive
(93/42/EEC)
Manufacturer name and address, manufacturing year
Power/Pause
KEY TO THE SYMBOLS

7
Direct TENS™
Intended Use
Direct TENS™ (882700) 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.
Intended User
The user of both the TensMed P82 and S82 can
be a Health Care Professional or a patient. The
device should be used indoors and may be used in a
healthcare facility setting or in a home environment.
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
• Radiating pain (e.g. back pain, cervicobrachial
syndrome)
• Amputation stump/phantom limb pain
• Pain from rheumatic diseases
Contraindications
Do not use Direct TENS™ in the following situations:
• If you have an implanted demand pacemaker,
intracardiac defibrillator 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.
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 fulfil the biocompatibility
requirements of the applicable standards.
. POINTS TO NOTE BEFORE USE

8
Direct TENS™
Contraindications
• Implanted electronic devices. Do not use the device on patients who have a cardiac pacemaker, implanted
defibrillator, or other implanted electronic device, because this may cause electric shock, burns, electrical
interference, or death.
• TENS for Undiagnosed Pain. Do not use the device as a TENS device on patients whose pain syndromes are
undiagnosed.
Warnings
• Consult with physician. Consult with the patient’s physician before using the device, because the device
may cause lethal rhythm disturbances to the heart in susceptible individuals.
• Skin condition. Apply stimulation only to normal, intact, clean, healthy skin.
• Long term eects. The long-term eects of chronic electrical stimulation are unknown.
• Stimulation location. Stimulation over Neck or Mouth. Do not apply stimulation over the patient’s neck
(especially the carotid sinus) or the patient’s mouth, because this could cause severe muscle spasms
resulting in closure of the airway, diculty in breathing, or adverse eects on heart rhythm or blood
pressure.
• Stimulation across Chest. Do not apply stimulation across the patient’s chest, because the introduction of
electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
• Across the head. Since the eects of stimulation of the brain are unknown, stimulation should not be
applied across the head, and electrodes should not be placed on opposite sides of the head.
• Stimulation over compromised skin. Do not apply stimulation over open wounds or rashes, or over
swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
• Stimulation near cancerous lesions. Do not apply stimulation over, or in proximity to, cancerous lesions.
• Stimulation over eyes. Do not apply stimulation directly on the eyes.
• Environment. Electronic monitoring equipment. Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the
electrical stimulation device is in use.
• Bath or Shower. Do not apply stimulation when the patient is in the bath or shower. Do not apply
stimulation in humid atmosphere exceeding 75% of relative humidity.
• Sleeping. Do not apply stimulation while the patient is sleeping.
• Driving or operating machinery. Do not apply stimulation while the patient is driving, operating machinery,
or during any activity in which electrical stimulation or involuntary muscle contraction can put the patient
at risk of injury.
• Electrosurgical equipment or defibrillators. Disconnect the stimulation electrodes before using electrosurgical
equipment or defibrillators. Otherwise skin burns may be caused below the electrodes and the device
might be destroyed.
• Magnetic Resonance Imaging. Do not wear electrode or the device during Magnetic Resonance Imaging
(MRI) scans as this may result in metal overheating and causing skin burns in the area of the electrode.
• Flammable or explosive environment. Do not use the device in areas where there is a risk of fire or
explosion, such as oxygen-rich environments, in the vicinity of flammable anaesthetics, etc.
• Power supply. Never connect stimulation cables to an external power supply as there is a risk of electric
shock.
• Near other equipment. Do not use the device beside or stacked on top of any other equipment. If you must
use it side by side or on top of another system, you should check that the device works properly in the
chosen configuration.
• Miscellaneous. Electrodes for Single Patient. Do not share electrodes with other persons. All users should
have individual set of electrodes to prevent undesirable skin reactions or disease transmission.
PRECAUTIONARY MEASURES

9
Direct TENS™
• Accessories. Use this device only with the leads, electrodes, and accessories recommended by the
manufacturer. Use of other accessories may adversely aect the performance of the device or may result in
stronger electromagnetic emissions or reduce the electromagnetic immunity of the device.
• No Modification. No modification of the equipment is allowed.
Precautions
• Supervision. Use this device only under the continued supervision of a licensed practitioner. Electrode
placement and stimulation settings should be based on the guidance of the prescribing practitioner.
• Manufacturer. The manufacturer does not take any responsibility for any electrode placements other than
recommended.
• Pregnancy. The safety of electrical stimulation during pregnancy has not been established.
• Skin irritation. Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel). The irritation may be reduced by using an alternate
conductive medium or alternate electrode placement. Some patients may experience redness under the
electrodes after a session. This redness usually disappears within a few hours. Advise the patient to consult
the clinician if the skin redness does not disappear after a few hours. Do not start another stimulation
session in the same area if the redness is still visible. Don’t scratch the redness area.
• Heart Disease. Patients with suspected or diagnosed heart disease should follow precautions
recommended by their physicians.
• Epilepsy. Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
• Internal Bleeding. Use caution when the patient has a tendency to bleed internally, such as following an
injury or fracture.
• After Surgery. Use caution following recent surgical procedures when stimulation may disrupt the patient’s
healing process.
• Over uterus. Do not place electrodes directly over the uterus or connect pairs of electrodes across the
abdomen if you are pregnant. The reason is that, theoretically, the current could aect the foetus’s heart
(although there are no reports of it being harmful).
• Lack of sensation. Use caution if stimulation is applied over areas of skin that lack normal sensation. Don’t
apply stimulation on patient unable to express themselves.
• Stimulation. The stimulator should only be used with skin electrodes intended for nerve and muscle
stimulation. Muscle soreness may occur after stimulation but usually disappears within a week.
• Hot casing or batteries. Under extreme use conditions, some parts of the casing might reach up to 109 °F
(43 °C). Use caution when manipulating the batteries right after device use or when holding the device.
There is no particular health risk associated with this temperature besides your comfort.
• Children. Keep this device out of the reach of children.
• Electrode Size. Do not use electrodes with an active area less than 16 cm2, as there will be a risk of
suering a burn injury. Caution should always be exercised with current densities more than 2mA/cm2.
• Strangulation. Do not wrap leadwires around your neck, and keep them out of the reach of children.
Strangulation may result from entanglement in the leadwires.
• Tripping. Care should be used to avoid tripping on lead wires.
• Damaged Device or Accessories. Never use the device or any of its accessories if it is damaged (case, cables,
etc.) or if the battery compartment is open as there is a risk of electric shock. Carefully inspect the lead
wires and connectors prior to each use.
• Inspect Electrodes. Inspect electrodes before each use. Replace electrodes when they begin to deteriorate
or lose adhesion. Poor contact between the electrodes and the patient’s skin increases the risk of skin
irritation or burns. Electrodes will last longer if used and stored according to instructions on electrode
packaging. Attach the electrodes in such a way that their entire surface is in contact with the skin.
• Foreign bodies. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the device and the
battery compartment.

10
Direct TENS™
• Batteries. Do not carry batteries in a pocket, purse, or any other place where the terminals could become
short-circuited (e.g. by way of paper clip). Intense heat could be generated and injury may result. Never
open the battery cover during stimulation in order to avoid electrical shock. Remove the batteries from the
device if you do not intend to use it for a prolonged period of time (more than 3 months). Extended storage
of the batteries in the device might lead to batteries and device damage.
• Cable. The cable is best preserved if left attached to the stimulator between sessions. Do not jerk the cable
or connection.
• Heat and Cold products. The use of heat or cold producing devices (e.g. electric heating blankets, heating
pads or ice packs) may impair performance of the electrode or alter the patient’s circulation/sensitivity and
increase the risk of injury to the patient.
• Pulled muscles. Do not apply electrodes over pulled muscles. Using the stimulator on a previously extended
muscle might further pull such muscle. The higher the stimulation intensity, the higher the risk to further
overextends such muscle.
• Additional Precautions for TENS
– TENS is not eective for pain of central origin, including headache.
– TENS is not a substitute for pain medications and other pain management therapies.
– TENS devices have no curative value.
– TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise
serve as a protective mechanism.
• Eectiveness of TENS is highly dependent upon patient selection by a practitioner qualified in the
management of pain patients.
Dangers
• Electrodes. Any Electrode with a minimum active area of 16 cm² may be used with this device. Use of an
electrode with an area less than 16 cm² can cause burns when the unit is used at higher intensities. Consult
your clinician prior to using any electrode less than 16 cm².
Adverse Reactions
• Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin.
• Patients may experience headache and other painful sensations during or following the application of
electrical stimulation near the eyes and to the head and face.
• Patients should stop using the device and should consult with their physicians if they experience adverse
reactions from the device.
• Precaution: Do not disconnect any stimulation cables during a session while the stimulator is switched on.
Switch the stimulator o first. Always turn o the stimulator before moving or removing any electrodes
during a session.
• Precaution: Do not use electrodes with an active area less than 16 cm2, as there will be a risk of suering a
burn injury. Caution should always be exercised with current densities more than 2mA/cm2.
• Precaution: Do not apply stimulation in the vicinity of metal. Remove jewelry, body piercings, buckles or
any other removable metallic product or device in the area of stimulation. Never use the electrodes contra-
laterally, i.e. do not use two pins connected to the same channel on opposite segments of the body.
• Precaution: Never carry out an initial stimulation session on a person who is standing. The first five minutes
of stimulation must always be performed on a person who is sitting or lying down. In rare instances, people
of a nervous disposition may experience a vasovagal reaction. This reaction is connected with fear of the
muscle stimulation as well as surprise at seeing one of their muscles contract without having intentionally
contracted it themselves. A vasovagal reaction causes heart to slow down and blood pressure to drop,
which can make you feel weak and faint. If this does occur, stop the stimulation and lie down with the legs
raised until the feeling of weakness disappears (5 to 10 minutes).
• Precaution: Sudden temperature changes can cause condensation to build up inside the stimulator. To prevent
this, allow it to reach room temperature before use.