Omron E3 Intense, HV-F021-EW, HV-F021-ESL Instruction Manual

Pain Reliever
E3 Intense (HV-F021-ESL)
Instruction Manual
• Pain Reliever. Instruction Manual.
• Appareil anti-douleur. Mode d’emploi.
• Schmerztherapiegerät. Gebrauchsanweisung.
• Dispositivo per il trattamento del dolore. Manuale di istruzioni.
• Dispositivo para alivio del dolor. Manual de instrucciones.
• Apparaat ter verlichting van pijn. Gebruiksaanwijzing.
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• A÷rÕ Giderici. KullanÕm KÕlavuzu.
IM-HV-F021-E-05-03/2018
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9200776-0E
Table of contents
Before using the unit
Introduc tion ........................................................................................................................................3
Intended use ......................................................................................................................................3
Important safety precautions and warnings ......................................................................................4
Know your unit ...................................................................................................................................8
Package contents ..........................................................................................................................8
Optional medical accessories .......................................................................................................8
Buttons and their functions ............................................................................................................9
Operating instructions
Assembly steps ................................................................................................................................10
STEP 1 – Insert batteries ............................................................................................................10
STEP 2 – Attach the electrode cord to the main unit ..................................................................10
STEP 3 – Snap either electrode cord to each of the pads ..........................................................11
STEP 4 – Remove and discard plastic ¿ lm from pads (in case of new pads) ............................11
STEP 5 (Optional) – Attach the unit to the belt clip .....................................................................11
Get started with your therapy .........................................................................................................12
STEP 1 – Pad placement ............................................................................................................12
STEP 2 – Select 1 of 9 modes ....................................................................................................15
STEP 3 – Select the correct intensity level (1 low – 15 high) ......................................................16
How to manage and reduce your pain .............................................................................................17
When should I start therapy? ......................................................................................................17
How long should you use it? .......................................................................................................17
When to stop using the unit? .......................................................................................................17
Care and maintenance
Cleaning and storage .......................................................................................................................17
Cleaning the pads ........................................................................................................................17
When should you replace your pads? ........................................................................................18
Cleaning the unit ..........................................................................................................................18
Storing the pads ...........................................................................................................................18
Storing the unit and pads .............................................................................................................18
Troubleshooting ...............................................................................................................................19
Technical data ..................................................................................................................................21
Important information regarding Electro Magnetic Compatibility (EMC) ....................................... 23
Warranty ...........................................................................................................................................24
2
Introduction
Thank you for purchasing OMRON E3 Intense. In order to use the unit safely, read the complete manual carefully before using the unit for the ¿ rst time.
How does it work?
E3 Intense uses Triple Action TENS (Transcutaneous Electrical Nerve Stimulation) technology that helps to:
- block the pain message
- trigger the release of endorphins (natural pain killers)
- improve the blood circulation (as result of repeated muscle contracting and relaxing)
Intended use
Medical purpose
OMRON E3 Intense is a Pain Reliever intended for reducing and relieving muscles and joints pain, stiffness and numbness in the back, arms, legs, shoulders and feet by applying electrical nerve stimulation to the surface of the skin near the site of the pain. It should be applied to normal, healthy, dry, and clean skin of adult patients. Any of the modes can safely be used on body parts or pains described in this manual. Just ¿ nd one that feels good and is comfortable on your pain. It can be successfully used in conjunction with any other pain treatment or medication.
Since the 1970s, pain relief based on TENS has been widely used by many healthcare professionals, such as physiotherapists and pain specialists.
Intended User
This unit is intended to be operated by adults who can understand this instruction manual. It is not for professional use in hospitals or other medical facilities, it is intended for home use only.
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Important safety precautions and warnings
It is important that you read all the warnings and precautions included in this instruction manual because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the unit.
SAFETY SYMBOLS USED IN THIS INSTRUCTION MANUAL
DANGER
WARNING
CAUTION
Do not use this unit with these other devices:
(1) If you have a pacemaker, implanted de¿ brillator, or other implanted metallic or electronic device.
Such use could cause electric shock, burns, electrical interference or death. (2) Do not use this device while using another TENS device. (3) Together with a life-supporting medical electronic device such as an arti¿ cial heart or lung or respirator. (4) For Hospitals and Clinics, in the presence of or when attached to the body, electronic monitoring equipment
(e.g. cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in
use. (5) For Hospitals and Clinics, simultaneous connection of a patient to a high frequency surgical Medical Electronic
equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator. (6) For Hospitals and Clinics, operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy Medical
Electronic equipment may produce instability to the stimulator output.
Do not use this unit under these conditions
Consult with your healthcare professional before using this unit. The unit may cause lethal rhythm
disturbances in certain susceptible individuals. If you have had a recent surgical procedure, the stimulation may disrupt the healing process.
Do not use on these individuals
Pregnant women.
Do not use on children or infants because this device has not been evaluated for pediatric use. Keep out of reach of young children because the electrode cord could cause strangulation. Persons incapable of expressing their thoughts or intentions. Persons incapable of operating the unit by themselves. Use caution if you have a tendency to bleed internally, such as following an injury or fracture. If you have suspected or diagnosed heart disease, you should follow precautions recommended
by your healthcare professional.
If you have suspected or diagnosed epilepsy, you should follow precautions recommended by
your healthcare professional.
Improper use may cause danger resulting in death or serious injury. These are situations in which the device should not be used.
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.
DANGER
4
Important safety precautions and warnings
Use caution if stimulation is applied over the menstruating uterus. NEVER APPLY THE PADS TO THESE BODY AREAS:
The head, the mouth, or any area of the face.
The neck or any area of the throat because this could cause severe muscle spasms resulting in closure of the airway, dif¿ culty in breathing, or adverse effects on heart rhythm or blood pressure.
Do not use near the heart, or on genital area.
Open wounds or rashes or over swollen, red, infected or inÀ amed areas or skin eruptions (such as varicose veins, phlebitis, thrombophlebitis and thrombosis), or on top of or close to cancerous lesions, or over areas of skin that lack normal sensation.
Both sides of the thorax simultaneously (lateral or front and back), or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal.
On the calves of both legs at the same time because this may cause cardiac disturbance.
On the bottom of both feet at the same time because this may cause cardiac disturbance.
Do not use this unit during these activities
When in the bath or shower;
While sleeping; While driving, operating machinery, or during any activity in which electrical stimulation can put
you at risk of injury.
Pain management warnings
If you have had medical or physical treatment for your pain, consult with your healthcare
professional before using this unit.
If your pain does not improve, becomes seriously chronic or severe, or continues for more than 5
days, stop using the unit and consult with your healthcare professional.
The mere existence of pain functions as a very important warning telling us that something is
wrong. Therefore, if you suffer from any serious illness, consult your healthcare professional in order to con¿ rm that it is advisable for you to use this OMRON E3 Intense.
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Important safety precautions and warnings
Do not alter the unit
Do not plug this cord into any other device that is not an OMRON E3 Intense. No modi¿ cation of this unit is allowed. Use this unit only with the leads, electrodes, and accessories recommended by the manufacturer
to avoid damage to the unit.
Warnings regarding the pads
Apply pads to normal, healthy, dry, and clean skin (of adult patients) because it may otherwise
disrupt the healing process.
If you experience any skin irritation or redness after a session, do not continue stimulation in that
area of the skin.
Precautions regarding the pads
Do not move the pads to another location while the unit is on. Therapy won’t work with just 1 pad. You must use 2 pads at the same time. Make sure the components are connected well and the pads are ¿ xed on the part of the body you
wish to treat or the therapy may not be effective. Pads should not touch any metal object, such as a belt buckle, necklace, or other metal worn
under clothing. Do not overlap pads or put pads on top of each other. It may weaken or stop therapy, or the unit
may stop working.
Gel pads may also stick together and cause gel to be removed when separating.
Do not share pads with another person. This may cause a skin irritation or infection. Pads are
intended for use by one person. Do not leave pads attached to the skin after treatment. Do not bend or fold because the gel may get damaged and it won’t stick or function properly. To avoid damage to the adhesive surface of the pads, put the pads only on the skin or on the
plastic pad holder provided to avoid damage to the adhesive surface of the pads.
Always place clean pads in accordance with illustrations provided (Refer to pages 12-14, Pad
Placement). Do not apply ointment or any solvent to the pads or to your skin because it will disrupt the pads
from functioning properly. The self-adhesive pads will adhere to your skin.
Place pads at least 3 cm apart for optimal results.
Caution while using the unit Main unit
If the unit is not functioning properly or you feel discomfort, immediately stop using the unit. Do not use for any other purpose except for what it is intended for. Do not place in a room with high humidity, such as a bathroom. This will damage the unit. Ideal
temperature for using +10 - +40 °C, 30 - 80 % relative humidity. Do not use the unit without proper lighting. You may not be able to operate the unit successfully. While using this device, make sure that no mobile phone or any other electrical devices that
emit electromagnetic ¿ elds is within 30cm. This may result in degradation of performance of the
device.
6
Important safety precautions and warnings
Cord
Do not insert the electrode plug into any place other than the jack on the unit. Do not pull on the electrode cord during treatment. Do not bend or pull the end of the cord. When pulling out the cord from the unit, hold the plug and pull. Replace the cord when broken or damaged.
Battery
Do not throw the batteries into a ¿ re. The batteries may explode. Dispose of the unit, batteries, and components according to applicable legal regulations.
Unlawful disposal may cause environmental pollution. Do not mix alkaline and manganese batteries as this will shorten the battery life. During therapy, do not remove the battery cover and do not touch the battery terminals. Use the battery within recommended period mentioned to it.
Pads
Detach the pads before replacing the batteries.
General precautions
The long-term effects of electrical stimulation are unknown. Apply stimulation to only normal, intact, clean, dry, and healthy skin. TENS is not effective in treating the original source or cause of the pain, including headache. TENS is not a substitute for pain medications and other pain management therapies. TENS devices do not cure disease or injuries. TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would
otherwise serve as a protective mechanism. You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical
conductive medium (gel). Keep the unit away from young children. The unit contains small pieces that may be swallowed.
Immediately contact your healthcare professional.
Possible adverse reactions
You should stop using the unit and consult with your healthcare professional if you experience
adverse reactions from the unit. You may experience skin irritation beneath the stimulation electrodes applied to your skin. Do not use to treat one region for extended periods of time (more than 2 × 15 minutes a session,
up to 3 times/day) or muscles in that region may become exhausted and sore.
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Know your unit
Package contents
Main unit Electrode cord Pad holder
Long Life Pads Batteries for trial use Belt clip
Soft pouch Instruction manual
IM-HV-F021-E-05-03/2018
9200776-0E
Optional medical accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
• Long Life Pads
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