Chattanooga Cefar TENS User manual

Cefar TENS
User Manual

CONTENTS
EN
CEFAR TENS
. Introduction...................................................................................................................................................................................
. How to use the medical equipment (Intended Use)...............................................................................................
. Fields of Application...................................................................................................................................................................
. Therapy objectives.....................................................................................................................................................................
. Contraindications.......................................................................................................................................................................
. Warnings.........................................................................................................................................................................................
. Overview........................................................................................................................................................................................
. Device components and accessories.................................................................................................................................
. Explanation of symbols ..........................................................................................................................................................
. Description of the Cefar Tens.............................................................................................................................................
. Description of the device........................................................................................................................................................
. Explanation of symbols...........................................................................................................................................................
. Battery Charge............................................................................................................................................................................
. Accessories...................................................................................................................................................................................
. Step by step use - Patient mode......................................................................................................................................
. Attach the electrodes..............................................................................................................................................................
. Switch on the stimulator......................................................................................................................................................
. Select a preset Program.......................................................................................................................................................
. Adjust timer settings if needed ........................................................................................................................................
. Start the stimulation...............................................................................................................................................................
. Key Lock........................................................................................................................................................................................
. Program pause..........................................................................................................................................................................
. Open lead....................................................................................................................................................................................
. Resume treatment after open lead.................................................................................................................................
. Program end............................................................................................................................................................................
. Physician Mode..........................................................................................................................................................................
. To access Physician Mode......................................................................................................................................................
. Physician Mode home screen ............................................................................................................................................
. Lock Program.............................................................................................................................................................................
. Custom Programs....................................................................................................................................................................
.. Select custom Programs.....................................................................................................................................................
.. Custom Program first screen..........................................................................................................................................
.. Summary screen....................................................................................................................................................................
.. Parameters range..................................................................................................................................................................
. Compliance..................................................................................................................................................................................
. CC-CV............................................................................................................................................................................................

EN
CEFAR TENS
. Accupuncture..............................................................................................................................................................................
.. Precautionary measures......................................................................................................................................................
.. Recommendations...............................................................................................................................................................
. Pain score....................................................................................................................................................................................
. Programs......................................................................................................................................................................................
. Program parameters...............................................................................................................................................................
. Program description................................................................................................................................................................
. Troubleshootings......................................................................................................................................................................
. Electrode or cable failure.......................................................................................................................................................
. Battery level................................................................................................................................................................................
. Others............................................................................................................................................................................................
. Care, Maintenance, Transport, Environmental Statement.............................................................................
. Maintenance..............................................................................................................................................................................
. Transport....................................................................................................................................................................................
.. Transport of the CEFAR TENS........................................................................................................................................
. Environmental Statement, Expected Life....................................................................................................................
. Technical Datas, Standards, Guarantee, Patients..................................................................................................
. Technical Data............................................................................................................................................................................
.. General information..............................................................................................................................................................
.. Stimulation Parameters......................................................................................................................................................
.. Information on electromagnetic compatibility (EMC).........................................................................................
.. Environmental conditions.................................................................................................................................................
. Standards......................................................................................................................................................................................
. Guarantee.....................................................................................................................................................................................
. Frequently Asked Questions............................................................................................................................................
. Contacts.......................................................................................................................................................................................
. Electrode placement guide...............................................................................................................................................

. INTRODUCTION
EN
CEFAR TENS
As part of Chattanooga, CEFAR stimulators are widely used and endorsed by medical professionals
around the world.
TENS is eective and economical. Through clinical research, areas of application for Transcutaneous
Electrical Neurostimulation (TENS) and Percutaneous Neurostimulation (PENS) are rapidly expanding.
Chattanooga/CEFAR is working actively to further develop the method towards a natural treatment
alternative for the patient.
CEFAR TENS is a dual channel nerve stimulator (TENS) designed for use by both professionals
and home users. It provides relief of a wide range of pains, like back pain and neuropathic pain.
The stimulator features  preset programs and  custom programs. Program and amplitude can
be individually set for each channel, which means that two dierent programs can be combined
simultaneously.
Chattanooga is the world’s largest manufacturer of rehabilitation and pain relief equipment. For over
seven decades, Chattanooga products have contributed to treating patients in hospitals, clinics and
home settings worldwide.
Chattanooga is a brand of DJO Global Inc. DJO Global provides solutions for musculoskeletal health,
vascular health and pain management. Our products help prevent injuries or rehabilitate after
surgery, injury or from degenerative disease and relieve pain enabling patients to regain or maintain
their natural motion. Visit www.DJOglobal.eu

. HOW TO USE THE MEDICAL EQUIPMENT INTENDED USE
EN
CEFAR TENS
. Therapy objectives
As a TENS device, indications are for the following conditions:
-Symptomatic relief and management of chronic, intractable pain
-Adjunctive treatment for post-surgical and post-trauma acute pain
-Relief of pain associated with arthritis.
With the Pain Relief programs, impulses are sent through the nerves to inhibit the pain impulses.
Pain relief is usually most ecient during stimulation, but the eect can also last after the program
has finished. It also increases the circulation. If the pain persists, seek medical advice.
As an NMES device, indications are for the following conditions:
-Retarding or preventing disuse atrophy
-Maintaining or increasing range of motion
-Re-educating muscles
-Relaxation of muscle spasms
-Increasing local blood circulation
. Fields of Application
The CEFAR TENS is a stimulator used by patients at home to ensure electric stimulation treatments
in pain management (TENS) and neuro muscular stimulation (EMS/NMES).
The CEFAR TENS is a stimulator used by medical professionals to apply Electro-Acupuncture and
neuro muscular stimulation (EMS/NMES) treatments
TENS = Transcutaneous Electrical Nerve Stimulation. TENS is an eective method oering pain
relief. TENS uses the central nervous system’s own pain relief mechanisms to reduce both acute and
chronic pain.
The CEFAR TENS unit is an important supplement to medical and therapeutic treatment for use in
hospitals, clinics, general practices and in the patient’s home.
Note
- This manual is considered as an accessory of the therapy unit and therefore it should
accompany it at all times.
- The specific instructions provided here are conditions for the intended use and correct
operation of the equipment as well as the safety of the patient and the operator using it.

EN
CEFAR TENS
The CEFAR TENS is a multifunctional electrotherapy unit that can be used on any occasion when
pain relief or muscle relaxation is needed. All the programs can be used as often as required.
Guidelines for using the preset treatment programs with indication examples, suggested electrode
placements and recommended treatment time are included in this manual.
. Contraindications
•Implanted electronic devices. Do not use the device if you have a cardiac stimulator, implanted
defibrillator or other implanted electronic/electrical device. This could cause an electrical shock,
burns, electrical interference or death.
• Epilepsy
• Pregnancy (do not use on abdominal region)
• Serious arterial circulation problems in lower limbs
• Do not use chest stimulation on patients with cardiac arrhythmia or angina pectoris
• Heart disease: If you have suspected or diagnosed cardiopathy you should follow the precautions
for use recommended by your doctor because the device may cause lethal rhythm disturbance to
the heart in susceptible individuals.
Note
Fixation metalwork and/or prosthesis equipment
The presence of fixation metalwork and/or prosthesis equipment (metallic equipment in
contact with the bone: pins, screws, plates, prostheses, etc) is not a contraindication for TENS
and NMES stimulation. The electrical current of the CEFAR TENS is specially designed to have
no harmful eect on osteosynthesis equipment.
Electro-stimulation should not be applied if any part of the implanted element going through
the patient's skin because this may cause shocks or burns.
Danger!
Do NOT use the CEFAR TENS on patients with:

. WARNINGS
EN
CEFAR TENS
Definitions
It is mandatory to read the safety statements before using the physiotherapy unit. The safety
statements are classified as follows:
Safety Information
Danger!
This term indicates an imminent hazard. If not avoided, this hazard could result in
death or serious injury.
Danger!
Explosion hazard - CEFAR TENS is not designed for use in areas where an explosion
hazard may occur. An explosion hazard may result from the use of flammable
anaesthetics, oxygen-rich environments, skin cleansing agents and disinfectants.
Caution!
This term indicates a potential hazard. If not avoided, this hazard can result in minor
personal injury and/or product/property damage.
Warning!
This term indicates a hazard. If not avoided, this hazard can result in death or serious injury.
Warning!
Patient hazard
− Only authorised individuals are allowed to repair the CEFAR TENS. Individuals are
authorised after receiving training in the operation of the unit and reading this
operating into the manual.
− Before using the therapy unit, the operator must ascertain that it is in correct working
order and operating condition. The cables and connectors, in particular, must be
checked for signs of damage. The device cannot be used if any part is damaged as
there is a risk of electrical shock.
− Stop therapy immediately if you have doubts about the device settings and/or the

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CEFAR TENS
therapy protocol.
− Patients must be fully conscious while being instructed in the use of the therapy unit
and during therapy.
- The choice of the therapy parameters to program and of the therapy protocols to use
is restricted to the responsible physician or therapist. It is the physician's or therapist’s
decision whether or not to use the unit on a specific patient.
− The patients must be familiar with the functions of the CEFAR TENS device allowing
them to stop therapy, if needed. Patients unable to operate the emergency stop
function e.g. paralytic patients, must never be left unattended during therapy.
− Any accessories used with CEFAR TENS must first be approved by the manufacturer.
Using of not specified accessories and detachable parts could be unsafe for the user.
− The utmost caution is advised under the following conditions. Depending on the
judgement of the responsible physician, the unit may only be applied under supervision
and with the parameters defined by the responsible physician. Otherwise the exercise
may be too strenuous for the patients with:
. Hypertension (> stage ), ischemic heart disease and cerebrovascular diseases
. Cardiovascular diseases
. Pregnancy
Never apply the electrodes:
• Near the head or on the eyes
• On the front and side of the neck (especially carotid sinus) 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.
• Counter-laterally, i.e. do not use two poles connected to the same channel on
opposite sides of the body.
• On or near skin lesions of any kind (swelling, burns, irritation, eczema, cancerous
lesion, etc)
• Crossing over the heart because the introduction of electrical current into the chest
might cause rhythm disturbance to the patient's heart, which could be lethal.
- If the person is pregnant do not place electrodes directly on the uterus area or
connect pairs of electrodes on either side of the abdomen to avoid any risk for the
mother and/or the baby. - Keep the device out of the reach of children
Warning!
- Keep the device out of reach of children
- Never leave the device unattended when it is switched on!
- After use, store the device in a safe place to avoid other people not informed to use the
device.
- This device is not a toy but a medical device. Misunderstanding its use can cause
damage!

EN
CEFAR TENS
Warning!
Shock hazard - Strictly observe the following warnings. Failure to do so could endanger
the lives of the patient, the user and other persons involved.
− Before use allow the CEFAR TENS to reach room temperature. If the unit has been
transported at temperatures below °C (°F), leave it to reach at room temperature
for about hours, until any condensation has disappeared.
− Electrosurgical equipment or defibrillators. Disconnect the electrodes from the
device before using electrosurgical equipment, or a defibrillator, to avoid cutaneous
burns from the electrodes and destroying the device.
−Electronic surveillance equipment. Do not apply stimulation near electronic
surveillance equipment (e.g. cardiac monitors, ECG alarms), as there is a risk they may
not work properly whilst the electrical stimulation device is being used.
− Electromagnetic radiation. Do not use the stimulator in areas in which unprotected
devices are used to emit electromagnetic radiation. Portable communications
equipment can interfere with the device.
− Cancer. Do not apply stimulation if you have progressive cancer or near any cancerous
tumour. The increased metabolism, caused by certain modes of stimulation, is likely to
encourage cancer cells to spread
− Muscle shortening. During the muscular contraction phase it is recommended to hold
the extremities of the stimulated limbs to avoid any shortening of the muscle during
contraction, which could cause cramps.
− Loss of sensation. Proceed with caution if stimulation is applied to areas of the skin
whose level of sensation is lower than normal. Do not apply stimulation to a person
who cannot express themselves.
− Battery leakage. If there is leak from a component, take steps to ensure the liquid does
not come into contact with skin or eyes. Should this occur, wash the aected area with
water and consult a doctor.
− Strangulation. Do not wind cables around the neck. Tangled cables can cause
strangulation.
− Post-surgery. Proceed with caution after recent surgery when stimulation may disrupt
the patient's healing process.
− Accessibility of the power adaptor. The plug socket must be close to the power
adaptor and be easily accessible.
- The CEFAR TENS must only be operated in dry rooms.
- Do not use the CEFAR TENS in water or in a humid atmosphere (sauna, bath, shower
etc.), etc.).
- When connecting the unit to other equipment or when creating a medical system,
check that the sum of leakage currents will not cause any hazard. Please contact DJO
GLOBAL if you have questions regarding this matter.
- No modification of this equipment is allowed.
- Do not open the product and its accessories as there is risk of electrocution.
− Before cleaning and service interventions, turn o the device.

EN
 CEFAR TENS
Warning!
Equipment malfunction - this warnings can prevent equipment malfunctions that result
in patient hazards
- Keep the unit away from such equipment and verify its performance before use.
- Do not use the CEFAR TENS within one metre of short wave or microwave devices as
this could alter the currents generated by the stimulator. If you are in any doubt as to
the use of the stimulator in close proximity to another medical device, seek advice from
the manufacturer of the latter or from your doctor.
- Exercise caution when using electrotherapy while the patient is connected to
monitoring equipment with electrodes attached to the body. Stimulation could disrupt
the signals sent to the monitoring equipment.
- Refer repair and maintenance to authorized persons. Persons are authorized after
training by a specialist trained and commissioned by the manufacturer.
- Inspect the CEFAR TENS and it's accessories for damage and loose connections at least
once a year. Damaged and worn parts must be immediately replaced with original
spare parts by authorized sta.
- Do not use the device if you are connected to a high-frequency surgical instrument as
this could cause skin irritation or burns under the electrodes.
− Liquids and foreign material (such as dust, metal etc) must not be allowed to enter
the device. If such material has entered into the units, it must be immediately checked
by a service technician, before it can be reused.
− Electricity supply. Never connect the stimulation cables to an external power supply, as
there is a risk of electrocution.
− Do not apply stimulation near the area of an implant, such as cochlear implants,
pacemakers, skeletal anchorage or electric implants. This could cause an electrical
shock, burns, electrical interference or death.
− Never use the CEFAR TENS or the AC adaptor if it is damaged or open. There is a risk of
electric shock.
− Disconnect the AC adaptor immediately if there is abnormal heating or smell, or if
smoke comes from the AC adaptor or the device.
Caution!
Patient hazard - these cautions need to be observed to avoid the risk of electrical
shock or other negative eects to the patient.
- Do not apply stimulation close to metal. Remove jewellery, piercings, belt buckles or
any other metallic product or device in the area of stimulation
- Be careful if the patient has sensitivity problems or is not able to communicate that he

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 CEFAR TENS
Caution!
- Do not expose the CEFAR TENS to direct sunlight, because some of the
components may reach unacceptably high temperatures.
- Make sure that pets or vermin do not contaminate the physiotherapy unit and keep
them away from it. Also, keep the unit clean and protect it from dust and lint. The
safety rules and regulations set forth apply in any case.
or she feels discomfort, however light.
− Never begin 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 is of psychological origin and is connected with a 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 produces a feeling weakness and a tendency
towards fainting. If this does occur, all that is required is to stop the stimulation and for
the person to lie down with the legs raised until the feeling of weakness disappears (
to  minutes)
- Do not disconnect any channel during the stimulation.
- Do not use the stimulator while driving or operating machinery or during any activity
in which electrical stimulation or involuntary muscle contraction can put the patient at
risk of injury.
- Do not apply stimulation during sleep.
- Do not use the stimulator at altitudes of over , meters.
- When using constant current mode, always turn o the stimulator before moving or
removing any electrodes during a session, to avoid electrical shock to the patient.
- Do not try to place electrodes on a body part not directly visible without assistance.
- Attach the electrodes in such a way that their entire surface is in contact with the skin.
- For obvious reasons of hygiene, each patient must have their own set of electrodes. Do
not use the same electrodes on dierent patients.
- Some patients with very sensitive skin may experience redness under the electrodes
after a session. Generally, this redness is completely harmless and usually disappears
after  to  minutes. Never start another stimulation session in the same area,
however, if the redness is still visible.
- When using the device to customize programs, take special care that the parameters
customized and applied by you to the patient are as you wanted them to be.

EN
 CEFAR TENS
Note
- For best results, wash and clean the skin of any oil and dry it before attaching the electrodes.
- Never use a set of adhesive electrodes for more than  sessions as the quality of the contact
between the electrode and the skin, which is essential for the patient's comfort and the
eectiveness of the stimulation, gradually deteriorates.
- For information on use and storage please consult the instructions found on the electrodes
packaging.
Note
Biocompatibility
Those parts of the CEFAR TENS unit that come into contact with the patient when used as
intended, are designed to fulfil the biocompatibility requirements of the applicable standards.
Caution!
- It is recommended to use the transport bag that comes with the unit, for transport
of the device, and to use a proper transport box to ship it.
- Always use the AC adaptor (power supply) provided by the manufacturer to recharge
the unit. Never use any other AC Adapter. This could damage the device and
generate electrical hazards.
- Only use electrodes supplied by the manufacturer. Other electrodes may have
electrical properties that are unsuitable for or may damage the CEFAR TENS.
- Do not place the electrodes in water.
- Do not apply solvents of any kind to the electrodes.
- Instructions for electrodes. See the usage and storage instructions displayed on the
bag of electrodes.
- Hot casing or battery. Under extreme use conditions, some parts of the casing
might reach up to  °F ( °C). Use caution when manipulating the rechargeable
battery right after device use or when holding the device. There is no particular
health risk associated with this temperature besides your comfort
- Size of electrodes. Do not use electrodes with an active area of less than  cm²
due to the risk of associated burning. Proceed systematically with caution when the
density of the current is over mA/cm².
- If the device is not used for an extended period, we recommend that you charge your
device every months. You should store the device in a dry and cool environment.

. OVERVIEW
EN
 CEFAR TENS
Quantity Description Part number
 CEFAR TENS device 
 Fast charger  EU,  UK,  US
 Set of  pin cables  mm 
 User manual and practical guide 
 Transportation pouch 
 Necklace and clip 
 Beltclip 
. Device components and accessories
Model: CEFAR TENS
Part number: ////
Your kit contains (included in delivery):
Electrodes are considered as option depending on markets.
. Explanation of symbols (connections and nameplates)
Follow the instructions of the user manual
Caution! Observe warnings set forth in operation manual!
The CEFAR TENS is a class IIa device with internal electric power and type BF applied
parts.
The power switch On/OFF button is a multi-function button.
The name and address next to this factory symbol is the manufacturer.
20xx
LATEX
FREE
REF
20xx
LATEX
FREE
REF

EN
 CEFAR TENS
The number next to this symbol is the article reference number
CE-2797 Device complies with Council Directive //EEC as amended, concerning medical
devices.
The number next to this symbol is the serial number
WEEE Mark (European Directive //EC). Indicates separate treatment from
general waste at end of life.
Keep dry
IP22 IP classification indicates the degree of protection and thus defines its suitability for
use under various ambient conditions.
Non-ionising radiation
Not made with natural latex rubber
Keep away from direct sunlight
Alternating current input on AC power supply
Direct current output from power supply
Protection class II equipment. The AC Power Supply device has double insulation.
Indoor use only
20xx
LATEX
FREE
REF
LATEX
20xx
LATEX
FREE
REF
20xx
LATEX
FREE
REF
20xx
LATEX
FREE
REF
20xx
LATEX
FREE
REF

. DESCRIPTION OF THE CEFAR TENS
EN
 CEFAR TENS
. Description of the device
A ON/OFF
B Program selection - Pause during
stimulation
C Increase/decrease amplitude increase/decrease
timer menu navigation
D Timer
E Confirm - Resume stimulation when paused
F Cables sockets
G Battery charger socket
H Belt clip holders
I Belt clip (can be reversed °)
D
B
B
CC
E
A
F
F
G
I
I
H
H

EN
 CEFAR TENS
 Battery Status
 Keyboard lock symbol
 Program number (left and right channel)
 Amplitude bargraph (left and right channels)
 Amplitude level in milli Ampere (mA) or Voltage (V)
 Remaining time
 Mixed freq - Muscle stimulation icon
 Pause
 Program end
 Open circuit (disconnect electrode or cable)
 Program Lock
. Explanation of symbols
   












EN
 CEFAR TENS
The CEFAR TENS is powered by a rechargeable battery.
A -To recharge the CEFAR TENS first disconnect the electrode cables from the device, then plug the
charger to a wall socket then connect the stimulator to the charger.
B- The battery level of charge is indicated on the treatment screen
C- When charging, the battery charge symbol is animated with a battery filling itself from empty to full.
D -When battery is fully charge at the end of charging process device will show %.
. Battery charge
Fig B
Fig A
Fig E - Full charge
Fig C - Low charge Fig D - Half charged

EN
 CEFAR TENS
Electrodes: The CEFAR TENS should be used with recommended DJO electrodes
The electrodes will eventually wear out and need to be replaced. It is recommended to replace after
approximately - times of usage.
Note: Stimulation comfort and treatment eectiveness are highly influenced by the quality of the
electrodes.
Neck Strap and Clip: The CEFAR TENS comes with a belt clip and a neck strap/clip allowing you to
wear the stimulator around your neck or on your belt and have your hands free during treatment.
. Accessories
To use the neck strap, fix the clip associated to
the hole at the top of the unit. (Fig A & Fig B)
The Belt clip can be rotated in order to have
the cable outputs on the bottom, or on the top
depending on the body area being stimulated.
To release the belt clip, push it downwards
(Fig C & Fig D).
Fig C
Fig D
Fig A
Fig B

. STEP BY STEP USE  PATIENT MODE
EN
 CEFAR TENS
You must read the contra-indications and safety measures described at the beginning
of this manual (Chapter  "Safety Information") prior using your stimulator.
- Connect the electrodes to the cables.
- Attach the electrodes to your body.
- Plug the stimulator cables into the two sockets on the base of the device. The two cables can be
connected simultaneously. The cables colours are dierent to simplify use and facilitate identification
of the two channels. Make sure to have the line of the connector upwards to insert the connector
into the right direction.
- The kit includes two mm pin-connector cables.
. Attach the electrodes
. Switch on the stimulator
Press the "On/O" button.
Note: last program configuration will always
be displayed by default.

EN
 CEFAR TENS
Press the Program "P" button for the left or right channel you want to adjust. The program number is
blinking on the screen. Push on up/down arrows of the same channel to increase or decrease the
program number and confirm with "OK". If you want to use both channels, then select a program for
the other channel. Any combination of programs is possible except for Program , which must be
selected for both channels.
Note: When selecting a program the amplitude must be set to . mA or .V for the channel
concerned. For further information on the programs, see section PRESET PROGRAMS.
. Select a preset Program
. Adjust timer settings if needed
Timer preset value can be either unlimited (--:--) or with a limited time . See program table
summary at the end of this manual. Press once the "timer" button, Channel  time value is blinking. To
adjust time press on adjust value buttons "up or down" and press "OK" to confirm
Press twice the timer button to select Channel  timer adjustment.