OMRON HV-F013 Electronic Nerve Stimulator Instruction Manual

OMRON HV-F013 Electronic Nerve Stimulator

INTRODUCTION

Thank you for purchasing the OMRON Electronic Nerve Stimulator. In order to use the unit safely, read the complete manual carefully before using the unit for the first time. Keep this instruction manual in a convenient place or store with the unit for future reference. This box contains the following components:

• 1 Main Unit
• 1 Electrode Cord
• 2 Long Life Pads
• 1 Pad Holder
• 2 “AAN’ Batteries (LR03)
• 1 Instruction Manual
• 1 Quick Start Guide / Pad Placement Guide

Intended Use

Medical purpose
OMRON Electronic Nerve Stimulator is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, feet and shoulder due to strain from exercise or normal household and work activities. It should be applied to normal, healthy, dry, clean skin of adult patients.

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.

HOW Electronic Nerve Stimulator WORKS

What is it?
The OMRON Electronic Nerve Stimulator unit is a portable device designed for adults only. It is designed to reduce and relieve muscle and joint pain, stiffness and numbness in the back, arms, legs, shoulder and foot by applying electrical nerve stimulation to the surface of the skin near the site of the pain. Any of the modes can safely be used on body parts or pains described in this manual or Quick Start Guide/Pad Placement Guide. Just find one that feels good and is comfortable on your pain. It can be successfully used in conjunction with any other pain treatment or medication.
This type of therapy, called Transcutaneous Electrical Nerve Stimulator (TENS), has been used for over 30 years by medical professionals such as physical therapists and chiropractors.

How does it work?
Scientific theory suggests that electrical stimulation therapy may work in several ways:

1. The gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from ever reaching the brain from the source of the pain.
2. The gentle electrical pulses increase the production of the body’s natural pain killer, such as endorphins.
3. Furthermore, it is thought that the electrical stimulation improves blood circulation as well. Muscles contract and relax with the flow of the electrical stimulation. With repeated contracting and relaxing, the blood flows in and out and the blood circulation is improved.

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.
• Danger Improper use may cause danger resulting in death or serious injury. These are situations in which the device should not be used.
• Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
• Caution 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.

A Danger
Do not use this unit with these other devices:

• If you have a pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock,
  bums, electrical interference or death.

• Do not use this device while using another TENS device.

•  Together with a life-supporting medical electronic device such as an artificial heart or lung or respirator.

• 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.

• For Hospitals and Clinics, Simultaneous connection of a patient to a high frequency surgical ME equipment may result in bums at the site of the stimulator electrodes and possible damage to the stimulator.

• For Hospitals and Clinics, operation in close proximity (e.g. Jm) to a shortwave or microwave therapy ME equipment may produce instability to the stimulator output.

DO NOT USE THIS UNIT UNDER THESE CONDITIONS
A Consult with your physician 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 the 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 physician.
• If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.
• Use caution if stimulation is applied over the menstruating uterus.
•  This device is not intended for use by persons (including children) whose physical, sensory or mental abilities are different or reduced, or lack of experience or knowledge unless such persons are afforded supervision or training to operate the appliance by a person responsible for their safety. Children should be supervised to ensure they do not use the equipment as a toy.

A 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, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Near the heart, or on genital area.
• On the calves of both legs at the same time because this may cause cardiac disturbance.
• On the soles of both feet at the same time because this may cause cardiac disturbance.

Open wounds or rashes or over swollen, red, infected or inflamed 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.
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 physician before using this unit.
• If your pain does not improve, becomes seriously chronic or severe, or continues for more than five days, stop using the unit and consult with your physician.
• 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 physician in order to confirm that it is advisable for you to use this Electronic Nerve Stimulator unit.
• If you have any infectious disease or illness, consult with your physician before using this unit.

DO NOT ALTER THE UNIT

• Do not plug this cord into any other device that is not an OMRON HV-F013.
• No modification of this unit is allowed.
• Use this unit only with the pads, cable, and accessories recommended by the manufacturer to avoid damage to the unit.

WARNINGS REGARDING THE PADS

• Apply pads to normal, healthy, dry, 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 one pad. You MUST USE TWO PADS at the same time.
•  Make sure the components are connected well and the pads are fixed on the part of the body you wish to treat or the therapy may not be effective.
• Pad 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 apply pads with wet hands.
• Do not leave pads attached to the skin after treatment.
• The pads are for the exclusive use of a single patient. Do not share pads with another person. This may cause a skin irritation or infection.
•  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.
• Always place clean pads in accordance with illustrations provided (Refer to [GET STARTED WITH YOUR THERAPY -STEP
• Pad Placement] [GET STARTED WITH YOUR THERAPY -STEP 1 – Pad Placement (continued)]).
• 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 2.5 cm apart for optimal results.

CAUTION WHILE USING 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°C – 40°C, 30% – 80% relative humidity.
•  Do not use the unit without proper lighting. You may not be able to operate unit successfully.

CORD

• Do not wash the electrode 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

BATTERY

•  Do not throw the batteries into a fire. 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.
• Do not use rechargeable batteries.

PADS

• Use only pads recommended by the manufacturer to avoid affect the safety and effectiveness of electrical stimulation.
• The electrical performance characteristics of pads may affect the safety and effectiveness of electrical stimulation.
• Applying pads incorrectly could result in discomfort or skin burns.
• Detach the pads before replacing the batteries.
• 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.
• Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients.
• You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).
• Keep unit away from young children. The unit contains small pieces that may be swallowed. Immediately contact your physician.

Possible Adverse Reactions

• You should stop using the unit and consult with your physician if you experience adverse reactions from the unit.
• You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.
• You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face.
• Do not use to treat one region for extended periods of time (more than 30 minutes a session, up to 3 times/day) or muscles in that region may become exhausted and sore.

KNOW YOUR UNIT

FEATURES

1. Five pre-set modes (Arm/Shoulder, Lower Back, Leg/Foot, Knead, Steady).
2. Ten intensity levels (1 low to 10 high).
3. Pair of pads (durable, re-usable, washable, up to 150 uses). (Only use OMRON manufactured pads or cord with this unit).
4. Automatic 15 minute shut off.
5. The lights let you clearly control your therapy with mode, intensity level.
6. Battery Light lights up to remind you to replace the batteries.
7. Pad Light blinks if pad(s) falls off.

BUTTONS AND THEIR FUNCTIONS

ASSEMBLY STEPS

Before using your unit, inspect these things.

1. Cord is not broken.
2. Pad gel is not damaged.
3. Electrode cord connection is not broken.
4. Unit is intact and working.
5. There is no battery leakage.

• STEP 1 – INSERT BATTERIES

  • Remove the battery cover using a hard object (such as the tip of a pen, thin screwdriver).

  • Insert batteries. Make sure the Ee 8 signs correspond when inserting batteries.

  • Reinstall the battery cover.

• STEP 2 – ATTACH ELECTRODE CORD TO THE MAIN UNIT
  Attach the electrode cord plug to the bottom of the main unit.

• STEP 3 – SNAP EITHER ELECTRODE CORD TO EACH OF THE PADS
  For the first time, take the pads out of the sealed package.

  • Do NOT turn unit on, until pads are on your skin.
  • You MUST USE BOTH PADS or stimulation will not work.

• STEP 4 – REMOVE AND DISCARD PLASTIC FILM FROM PADS
  For the first time, remove the clear plastic film from the back of the pad.

GET STARTED WITH YOUR THERAPY

• STEP 1 – PAD PLACEMENT
  For optimal therapy:

  • Place pads on either side of the pain, not directly on the pain.
  • Place pads at least 2.5 cm apart.
  •  MUST USE TWO PADS at a time for therapy to work.
  • Do not overlap pads or put on top of each other.
  • Do not add spray, lotions or creams to skin or pads.
  • Do not share pads.
    

ARM
Attach both pads on either side of the region where you feel pain.

SHOULDER
Attach both pads on the shoulder according to your pain.

SHOULDER
Attach one pad on the front and on the back of your shoulder.

• Do not use near the heart, on both sides of the thorax or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal.
  

• LOWER BACK
  Attach one pad below and above the region in pain, both on same side.

JOINT (ELBOW)
Attach both pads on either side of the joint with the pa.in.

JOINT (KNEE)
Attach both pads above the knee or above and below the joint with pain.

• STEP 2 – SELECT 1 OF 5 MODES
  • Press the Power button.
  • Press .a.(Up) or T(Down) button to choose 1 of the 5 modes. Modes cannot be combined.
  • Press the Set/Start button to select the mode. It will start the therapy at the intensity level of 1.

How to change modes during therapy?
If you want to change modes during therapy, press the Set/Start button and .a.(Up) or T(Down) button to select a new mode. You can only use ONE MODE at a time.
If you don’t press the Set/Start button to select the mode, the unit will automatically turn off after 3 minutes.

• STEP 3 – SELECT INTENSITY LEVEL (1 LOW-10 HIGH)
  The unit automatically starts at the inten1ity level of 1. Slowly increase the intensity level by pressing .a.(Up) button. You should feel a gentle pulsing sensation. How do I select the right intensity level for my pain? Each time you press .a.(Up) or T(Down) button, it moves to another level. If the stimulation sensation becomes weaker or disappears, increase the intensity. But, if the sensation is at all uncomfortable, press T(Down) button to decrease the intensity.

  • Press .a. for higher intensity.
  • Press T for lower intensity.
    If Pad Light is blinking, the unit

What intensity level is my unit on?
Press .a.(Up)/T(Down) button to increase/decrease the intensity. The Intensity Light moves up/down after pressing it once or twice (as shown below). Therefore, the light may not move up/down, but the intensity level does increase/decrease each time you press it.

How long is the therapy?
The unit will continue automatically for 15 minutes before it shuts off. If you want to stop the therapy while in use, press the Power button. We recommend a total of 30 minutes therapy in one  sitting, up to 3 times/day.

HOW TO CONTROL AND REDUCE YOUR PAIN

When should you start therapy?
Use as soon as your pain begins. Start with one session (the unit automatically turns off at 15 minutes).

Get to your pain early
If you get to your pa.in early, it may prevent the pa.in from becoming worse, or even chronic. It’s better for you to get it under control sooner so that it does not reach a high pain threshold where it limits your daily activities.

How long should you use it?
Start with one 15 minute session. Always turn unit off with pads still on. Rate your pain to check your progress, 1 low to 10 high. Stop therapy session if pain has reduced or stopped. Press the Power button to continue therapy for another 15 minute session.

What type of pain is it best for?
This therapy works best on acute pain because it is localized. Acute pain is pain in one area for less than 3 months. If you have chronic pa.in, you may have pain in more than one area and for longer than 6 months. Chronic pain may be compounded by other issues that this unit cannot address.
Remember, this unit does not cure your pa.in or the original cause of the pa.in. It provides temporary relief or reduction of pain so that you can control your life and activities better.

Before using, check these points to make sure overstating is working properly.

1. Make sure the cord i1 not broken.
2. Check that the pad adhesive stick. I and is not damaged.
3. The electrode cord connection Is not broken.
4. The unit i1 intact and in working order.
5.  There is no battery leakage.

See [IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

Possible Adverse Reactions]. Long-time treatment and strong stimulation may ca1JSe muscular fatigue and may generate adverse effects.

When to stop using the unit?

1. If you experienced an adverse reaction (skin irritation/ redness/burns, headache or other painful sensation, or if you feel any unusual discomfort).
2. If your pa.in does not improve, becomes seriously chronic and severe, or continues for more than fete dill.

CLEANING AND STORAGE

The unit is designed for repeated use over time. The pads are valid for 4 years in the unopened state and will last up to 150 or 5 months (baaed on use 1 time/day). Here are important cleaning and storage ln1tructlons:

Cleaning the pads

1. Turn the power off and remove the electrode cord from the pads.
2. Wash the pads when the adhesive surface becomes dirty and/or the pads are difficult to attach.
   • Wash the pad softly with your fingertips under slow running cold water for several seconds (do not use a sponge/ cloth/sharp object like a nail on adhesive side, do not use detergents, chemicals or soap).
3. Pads can be washed after 15 uses, approximately ten times for up to 150 uses. Do not wash the pads too long or too frequently.
4. Dry the pads and let the adhesive surface air-dry completely. Do not wipe with a tissue paper or cloth.
5. Pads are replaceable and can be purchased. Please consult your local OMRON representatives.
   The life of the pads may vary by how often you wash the pads, the skin condition, and how you store the pads.

When should you replace your pads?
If the pad no longer sticks to your skin or if more than 25% of the pad’s surface is not in contact with your skin.

Cleaning the unit

1. Turn unit off and disconnect the electrode cord from the pads.
2.  Clean with a lightly moistened cloth (or a cloth soaked in a neutral cleaning solution) and wipe gently.
   • Do not use chemicals (like thinner, benzene).
   • Do not let water get into the internal area.

Storing the pads

1. Turn the unit off and remove the cord ~ from the bottom of the unit. A
2. Remove the pads from your body.
3. Leave the electrode cord connected CS  Place the pads on the pad holder, one pad on each side with the sticky side of each pad on the pad holder.
4. Wrap the electrode cord around the pad holder.

Storing the unit and pads

• Place the unit, pads with electrode cord on pad holder, Pad Placement Guide and Instruction Manual inside the original box.
• Do not keep in areas subject to direct sunlight, high or low temperatures, humid area, near to fire, vibration, or shock. Storage temperature, o•c to 40°C, 30% – 80% relative humidity.
• Do not keep at places that can be easily reached by children.
• When not in use for a long period, remove the batteries before storage, to avoid liquid discharge from batteries.
• Do not wrap the electrode cord around the unit because it may damage the cord.

TROUBLESHOOTING

In case of any of the below problems occurs during use, first check that no other electrical device is within 30cm. If the problem persists, refer to the table below

SPECIFICATIONS

• Product Description Electronic Nerve Stimulator
• Model (code) HV-F013(HV-F013-AP)
• Electrical Characteristics 3V = (with two alkaline “A.AN’ batteries [LR03] or manganese [R03])
• Battery Life New batteries (two AAA alkaline batteries) will last for approx. 3 months (when used for 15
• minutes a day, Lower Back Mode, max. intensity).
• Energy Consumption Approx. 30mA
• Frequency Approx. I to 108Hz
• PULSE Duration 100 μsec
• Maximum Output Voltage 32V (during soon load)
• Power Control IO intensity levels
• Oeerating Temperature, Humidity (When using product)
• 10 °C to 40 °C, 30 to 80% RH
• Storage Temperature, Humidity o •c to 40 •c, 30 to 80% R
• Transportation Temperature, Humidity, -20 •c to 60 •c, 10 to 95% RH.
• Air Pressure 700 to 1060 hPa
• Weight Approx. 75g (incl. batteries)
• Outer Dimension Approx. 7S x 70 x 22mm
• (Width x Height x Depth)
• Classification of ME equipment Internally powered
• IP classification IP22*
• Applied Part fype BF (Pads)
• Contents Main Unit, Electrode Cord, ~ Life Pads, Pad Holder, 2 “AAA” Batteries(LR03), Instruction
• Manual, Quick Start Guide/Pad lacement Guide

NOTE:

• This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co. Ltd., Japan.
• Designed for a minimum of 5 years life expectancy.
• Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device. ‘IP22 IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This device is protected against solid foreign objects of 12.5 mm diameter and greater such u a finger. This device is protected against oblique falling water drops which may cause issues during a normal operation.
  

Important information regarding Electromagnetic Compatibility (EMC)
HV-F0I3 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to EN60601-l-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at http://www .omronhealthcare-ap.com/emc-information. Refer to the EMC information for HV- F0I3 on the website.

Correct Disposal of this Product {Waste Electrical & Electronic Equipment)
1t This marking shown on the product or its literature, indicates that it should not be disposed with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product, or their local government
office, for details of where and how they can take this item for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product should not be mixed with other commercial wastes for disposal.
This product does not contain any hazardous substances. Disposal of used batteries should be carried out in accordance with the national regulations for the disposal of batteries.

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