Cefar TENS Electrotherapy Unit User Manual Rev B Feb 2020

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7.7 Accupuncture...27 7.7.1 Precautionary measures...27 7.7.2 Recommendations...28 7.8 Pain score...29 8. Programs...30 8.1 Program parameters...30 8.2 Program description...31 9. Troubleshootings...33 9.1 Electrode or cable failure...33 9.2 Battery level...33 9.3 Others...34 10. Care, Maintenance, Transport, Environmental Statement...36 10.1 Maintenance...37 10.2 Transport...37 10.2.1 Transport of the CEFAR TENS...37 10.3 Environmental Statement, Expected Life...38 11. Technical Datas, Standards, Guarantee, Patients...39 11.1 Technical Data...39 11.1.1 General information...39 11.1.2 Stimulation Parameters...39 11.1.3 Information on electromagnetic compatibility (EMC)...40 11.1.4 Environmental conditions...40 11.2 Standards...41 11.3 Guarantee...41 12. Frequently Asked Questions...42 13. Contacts...43 14. Electrode placement guide...44

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1 . I NT R O D U C T I ON

As part of Chattanooga, CEFAR stimulators are widely used and endorsed by medical professionals around the world. TENS is effective 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 10 preset programs and 5 custom programs. Program and amplitude can be individually set for each channel, which means that two different 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

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2 . H O W TO U SE T H E M E D I C A L E Q U I P M ENT ( I NTEN D E D U SE )

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.

2 . 1 Fi eld s 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 effective method offering 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.

2 . 2 Ther apy 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 efficient during stimulation, but the effect 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

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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.

2 . 3 Contr ai nd i cations

Danger! Do NOT use the CEFAR TENS on patients with:

• 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 effect 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.

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3. WARNINGS

D ef i ni ti ons It is mandatory to read the safety statements before using the physiotherapy unit. The safety statements are classified as follows:

Danger! This term indicates an imminent hazard. If not avoided, this hazard could result in death or serious injury.

War ning! This term indicates a hazard. If not avoided, this hazard can result in death or serious injury.

C auti on! This term indicates a potential hazard. If not avoided, this hazard can result in minor personal injury and/or product/property damage.

S afety Infor mation

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.

War ning! 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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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: 1. Hypertension (> stage 2), ischemic heart disease and cerebrovascular diseases 2. Cardiovascular diseases 3. 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, difficulty in breathing, or adverse effects 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

War ning! - 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!

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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 0 °C (32°F), leave it to reach at room temperature for about 2 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 affected 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 off the device.

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− 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.

War ni ng! 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 staff. - 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.

C auti on! Patient hazard - these cautions need to be observed to avoid the risk of electrical shock or other negative effects 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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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 (5 to 10 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 3,000 meters. - When using constant current mode, always turn off 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 different 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 10 to 20 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.

C auti on! - 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.

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C aution! - 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 118 °F (48 °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 10 cm² due to the risk of associated burning. Proceed systematically with caution when the density of the current is over 2 mA/cm². - If the device is not used for an extended period, we recommend that you charge your device every 5 months. You should store the device in a dry and cool environment.

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 40 sessions as the quality of the contact between the electrode and the skin, which is essential for the patient's comfort and the effectiveness 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.

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4. OVERVIEW

4 . 1 Devi ce components and accessories Model: CEFAR TENS Part number: 2053/2061/2075/2094/2106 Your kit contains (included in delivery):

Quantity

Description

Part number

1

CEFAR TENS device

1981

1

Fast charger

2001 (EU), 2133 (UK), 2145 (US)

1

Set of 2 pin cables 2 mm

1990

1

User manual and practical guide

13-00187

1

Transportation pouch

2049

2

Necklace and clip

2023

2

Beltclip

2037

Electrodes are considered as option depending on markets.

4 . 2 Explanati on of symbols (connections an d n amep lates)

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. 20xx

20xx

The power switch On/OFF button is a multi-function button.

The name and address next to this factory symbol is the manufacturer.

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LATEX FREE

REF

The number next to this symbol is the article reference number

CE-2797

Device complies with Council Directive 93/42/EEC as amended, concerning medical devices.

20xx

The number next to this symbol is the serial number 20xx

WEEE Mark (European Directive 2002/96/EC). Indicates separate treatment from general waste at end of life. 20xx

LATEX FREE

IP22 20xx

REF

Keep dry IP classification indicates the degree of protection and thus defines its suitability for use under various ambient conditions. Non-ionising radiation

LATEX FREE LATEX

REF

Not made with natural latex rubber

Keep away from direct sunlight LATEX FREE

REF

LATEX FREE

Alternating current input on AC power supply

Direct current output from power supply

REF Protection class II equipment. The AC Power Supply device has double insulation.

Indoor use only

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5 . D ES C R I P T I ON O F T H E C E F A R TENS

5 . 1 Descr i pti on 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 C H Belt clip holders I Belt clip (can be reversed 180°) B

E

C

B

A

F

D

F I G

H

H

I

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5 . 2 Explanati on of symbols 1 Battery Status 2 Keyboard lock symbol 3 Program number (left and right channel) 4 4 Amplitude bargraph (left and right channels) 5 Amplitude level in milli Ampere (mA) or Voltage (V) 7 6 Remaining time 6 7 Mixed freq - Muscle stimulation icon 8 Pause 9 Program end 10 Open circuit (disconnect electrode or cable) 11 Program Lock

3

2

7 6

5

5

10

9

1

4

8

11

3

9

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5 . 3 Batter y charge 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 100%.

Fig A

Fig B

Fig E - Full charge

Fig C - Low charge

Fig D - Half charged

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5 .4 Accessor i es 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 20-40 times of usage. Note: Stimulation comfort and treatment effectiveness 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.

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 A

Fig B

Fig C Fig D

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6 . STE P B Y STE P U SE - P A T I ENT M O D E

You must read the contra-indications and safety measures described at the beginning of this manual (Chapter 3 "Safety Information") prior using your stimulator.

6 . 1 Attach the electrodes - 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 different 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 2mm pin-connector cables.

6 . 2 Swi tch on the stimulator Press the "On/Off" button. Note: last program configuration will always be displayed by default.

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6 . 3 Select a pr eset Program 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 7, which must be selected for both channels. Note: When selecting a program the amplitude must be set to 00.0 mA or 0.0V for the channel concerned. For further information on the programs, see section PRESET PROGRAMS.

6 .4 Ad j ust ti mer 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 1 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 2 timer adjustment.

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6 . 5 Star t the stimulation Press the "INCREASE" button for each channel until you reach a comfortable level of stimulation. Press and hold the button to increase the amplitude gradually. Note: Always increase the amplitude cautiously! Note: Program 5 (TENS HAN): Set the amplitude for conventional stimulation (80 Hz) when the upper part of the high/low frequency symbol is flashing. When the stimulator switches over to burst after 3 seconds of stimulation (2 Hz) and the bottom part of the symbol is flashing, set the amplitude for this frequency. The frequencies switch every 3 seconds.

6 .6 Key L ock An automatically activated key lock prevents unintentional changes during treatment. The key lock is activated if no button is pressed for 10 seconds while stimulation is ongoing. Press any of the "DECREASE" buttons to deactivate the key lock.