WL-2405 - Anti-smoking electronic patch IBP - Free user manual and instructions

USER MANUAL WL-2405 IBP

O^2 Patch

Elektronisches Anti-Tabak-Pflaster Electronic Anti-Tobacco Patch Pansement électronique anti-tabac Elektronische antitatabakpleister Parche écétrico nico antitatabo

Instructions for Use 24

Mode d'emploi 46

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O^2 Patch

Electronic Anti-Tobacco Patch

Pansement electronique anti-tabac

Well-Life Healthcare Limited
1FI., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Geratotyp:

Gerät zur transkutanen elektrischen Nervenstimulation (TENS)

10.1 Service Adresse

ibp Service Center

Am Weimarer Berg 6
D-99510 Apolda
Germany

Tel.: [phone]

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

Seriennummer

1. How do these instructions for use support you?...25
2. How your O^2 Patch works.. 26
3. Your safety is important to us 27
   3.1 For which use is your O^2 Patch suited, and for which is it not? 28
   3.2 For which applications is your O^2 Patch suited, and for which is it not? 28
   3.3 When may you not use your O^2 Patch? 29
   3.4 Other factors you need to consider 30
4. How to protect your O^2 Patch 30
5. How to prepare your O^2 Patch for use 30
   5.1 Unpacking and checking the O^2 Patch 30
   5.2 Inserting the battery 32
6. How to conduct a session 34
   6.1 On which stimulation points may you apply your O^2 Patch? 34
   6.2 How long and how often may you use your O^2 Patch? 35
   6.3 How to use your O^2 Patch.. 36
7. How to clean and care for your O^2 Patch.... 39
   7.1 Cleaning 39
   7.2 Changing the patch 39
   7.3 Changing the battery 40
8. In case problems occur 41
9. Technical Data 42
10. Service and Warranty 43
    10.1 Service Addresses 43
    10.2 Warranty and Compensation for Damages 43
11. Disposal and Environmental Protection 44
    12.What does the designation on your product mean? 45

1. How do these instructions for use support you?

Warning!

This symbol warns you of possible health risks.

Caution!

This symbol alerts you of possible damage to your device.

Note

This symbol indicates particularly useful information regarding the use of your device.

Important components of your device have been marked with item numbers.

Using these item numbers you can safely identify displays and controls, the importance and use of which will be explained in these instructions.

Therefore you will find the item numbers placed in brackets in all corresponding paragraphs of these instructions for use.

2. How your O^2 Patch works

If you have decided to stop smoking, your O^2 Patch will effectively support you in keeping the unpleasant effects of nicotine withdrawal as low as possible. Typical effects are:

• constant desire (anguish) for nicotine and depression
• irritability, excessive appetite and sleep disorders.

These symptoms lead to physical reactions and nervousness, which generally are difficult to control.

Your O^2 Patch is an electronic Anti-Tobacco Patch, which is effective without nicotine or other active chemically-acting substances, and will therefore not lead to the undesirable effects of such substances.

Use of the O^2 Patch will help ease nervousness, excessive appetite and sleeping problems: Using a microprocessor-controlled stimulation program, current-induced stimuli of varying duration and intensity are transmitted to the nervous system. These stimuli are not painful. You will only feel a slight tingling sensation on the skin.

Try to get away from the nicotine addiction in two phases:

Addicted smokers typically have a habit such as lighting a cigarette before feeling the actual desire for nicotine. This habit should be recognized - it is best done with the support of a smoker counseling group. During the first phase your O^2 Patch will help you break down the habit in that it lowers typical states of tension. The objective of its application is to refrain from the habit of reaching for the cigarette.

When the urge for the cigarette becomes irresistible, you should consciously smoke no more than one cigarette. After this, you may not smoke again until the next irresistible urge develops.

During the first phase, which should last one to two weeks, daily application of your O^2 Patch for only 30 to 60 minutes in your neck area suffices.

The second phase is intended to completely end the addiction to tobacco. After your tobacco consumption has stabilized around 4-5 cigarettes a day, you will stimulate two areas:

neck
upper abdomen (Plexus)

The stimulation program is designed to alleviate the withdrawal symptoms, such as nervousness, excessive appetite and sleeping problems.

During the second phase, which should likewise last one to two weeks, daily application of your O^2 Patch for only about 30 minutes on each stimulation point suffices.

3. Your safety is important to us

Please read these instructions for use carefully before using your O^2 Patch for the first time. They contain everything you need to know to operate your O^2 Patch safely and to avoid damage.

These instructions for use are part of your device. Store these instructions for use carefully until you either pass your O^2 Patch on to a new owner along with these instructions or until you dispose of your O^2 Patch.

3.1 For which use is your O^2 Patch suited, and for which is it not?

Use the O^2 Patch exclusively in a private setting.
The O^2 Patch is not intended for commercial or medical use.
The O^2 Patch is intended exclusively in humans for external application on the stimulation points described in these instructions of use.
The O^2 Patch is not intended for application on children - not even under the permanent supervision of adults.

3.2 For which applications is your O^2 Patch suited, and for which is it not?

The O^2 Patch is suited exclusively to alleviate the nicotine withdrawal symptoms.
Nervousness, excessive appetite, sleep disorders and pain can also be symptomatic of a serious illness, thus excluding the self-treatment with the O^2 Patch.

Prior to its use, we recommend that you consult your physician, pharmacist or physiotherapist.

3.3 When may you not use your O^2 Patch?

Do not use the O^2 Patch

• if you suffer from cardiac problems, especially from cardiac dysrhythmias. The stimulation current can lead to ventricular fibrillation and in the worst case to cardiac arrest.
• if you have a pacemaker or other electronic implants. The stimulation current can interfere with the function of your implant.
  if you suffer from seizures. In severe cases the stimulation current can trigger convulsions.
  when pregnant. In severe cases the stimulation current can trigger contractions.
  if you suffer from allergic skin reactions. The electrodes and patch can lead to skin irritations.
  if you suffer from systemic illnesses, i.e. those affecting the entire body.
  if the O^2 Patch is damaged. The stimulation current can lead to aches and skin irritations.

3.4 Other factors you need to consider

Do not allow children access to your O^2 Patch.

Children could swallow small pieces and as a consequence suffocate.

1. How to protect your O^2 Patch

The electronics of your O^2 Patch tolerate neither wetness nor moisture.

Do not rinse the O^2 Patch under running water, do not immerse it in water or other fluids, and do not wear it while swimming or while in the sauna.

Your O^2 Patch is sensitive to heat.

Do not expose the O^2 Patch to direct sunlight, and do not place it on hot surfaces.

1. How to prepare your O^2 for use

5.1 Unpacking and checking the O^2 Patch

1. Unpack your O^2 Patch.

i Please save the original packaging so that you may send your O^2 Patch safely to our service department in case of repairs.
2. Check whether the scope of delivery is complete:

① O^2 Patch with inserted electrode patch and protective foil
② Battery
③ Protective cover
(4) Instructions for use

1. Check your O^2 Patch for possible damage from transport.

If your O^2 Patch should be damaged, please contact our service department (see Service and Warranty).

4

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5.2 Insert battery

If the battery has not yet been inserted:

1. Unwrap battery.
2. Open battery compartment: Push down the cover using your thumb and slide back.

1. Insert battery.

The "+" symbol on the battery must face up.

1. Close battery compartment.

If the battery has already been inserted:

1. Open battery compartment: Push down the cover using your thumb and slide back.

1. Remove battery.

1. Remove safety strip.
2. Reinsert battery.

The "+" symbol on the battery must face up!

1. Close battery compartment.

6. How to conduct a session

Apply the O^2 Patch only on such stimulation points of the skin that are described in this section. Do not use the device O^2 Patch

on the eyelids. The stimulation current can damage the eye.
in the laryngeal or pharyngeal areas. The stimulation current can lead to muscle cramping and possibly to suffocation.
such that the current flows directly across the heart (e.g. in direct vicinity of the heart). The stimulation current can lead to ventricular fibrillation and in severe cases to cardiac arrest.
such that the current flows directly across the brain (e.g. on the temples). The stimulation current can trigger convulsions.

6.1 On which stimulation points may you apply your O^2 Patch?

During your applications, maintain a minimum distance of 1m to microwave devices and short-wave devices. Electromagnetic interaction may impair the function of the O^2 Patch.

During the first phase, stimulate the neck (Zone 1). Attach the O^2 Patch as high as possible to the hair line.

During the second phase, stimulate the neck (Zone 1) and upper abdomen (Zone 2)

6.2 How long and how often may you use your O^2 Patch?

Do not exceed the listed application duration and frequency. It will not increase its effectiveness.

During the first phase, try to perform the application over a period of one to two weeks:

Stimulate Zone 1 – the neck – daily for 30 to 60 minutes.

During the second phase, also try to perform the application over a period of one to two weeks: Stimulate Zone 1 – the neck – and Zone 2 – the upper abdomen – daily for 30 minutes, respectively.

The overall daily application duration during the second phase is 2 × 30 minutes = 60 minutes.

You may also repeat the application at a later time: Always use the O^2 Patch when you want to avoid or reduce tension right from the start in order to suppress the desire for a cigarette.

6.3 How to use your O^2 Patch

Always use the O^2 Patch away from microwave devices or short-wave devices. Electromagnetic interaction may impair the function of the O^2 Patch.

1. Remove the protective foil from the electrode patch.
2. Apply the O^2 Patch to one of the stimulation zones.

Apply the O^2 Patch only to clean, dry, healthy skin that has not been treated with cosmetics and creams.

The O^2 Patch must adhere firmly to the skin. Replace the electrode patch when its adhesiveness has subsided.

1. Turn on the O^2 Patch: Push the ON+ button once. The illuminated display blinks red.

① ON+ button
② Illuminated display
③ OFF- button

1. Adjust the stimulation intensity. In Phase 1 and Phase 2 an average output of step 3 or 4 is recommended:

The intensity of the stimulation is increased with the ON+ button and decreased with the OFF- button. You may set the intensity of the stimulation to 10 different levels.

• Repeatedly press the ON+ button until you have reached the highest stimulation intensity that feels comfortable to you. The brightness of the illuminated display increases with the amount of stimulation intensity.
• Repeatedly press the OFF- button if you would like to lower the stimulation intensity. The brightness of the illuminated display decreases with the decreasing stimulation intensity.

i Your O^2 Patch automatically turns off after 15 minutes. Turn the O^2 Patch back on if you wish to continue the application.

Lower the stimulation intensity or turn off the O^2 Patch if the effect should become unpleasant.

1. How to turn off the O^2 Patch: Press the OFF- button repeatedly until the illuminated displays turns off.

Remove the electrode patch from the skin only in off-mode.

1. Remove the O^2 Patch from the skin: Slide a finger underneath the electrode patch and lift up the electrode patch.
2. Moisten the back of the electrode patch with a drop of water each on the left and right sides to protect the electrode patch from drying out.
3. Apply the O^2 Patch to a different stimulation point or

4. Terminate the application:

5. Apply the protective foil to the electrode patch.

6. Place the O^2 Patch inside the protective cover.
7. Store the O^2 Patch out of the reach of children and protected from sunlight and moisture until the next application.

7. How to clean and care for your O^2 Patch

7.1 Cleaning

1. Turn off the O^2 Patch.
2. Clean the housing with a damp cloth.

Do not clean the housing with caustic or abrasive cleansers.
Do not sterilize the electrode patch or the device itself in a steam sterilizer or in a cold sterilizing bath.

7.2 Changing the patch

Replace the electrode patch when it is dirty or worn.

1. Turn off the O^2 Patch.
2. Remove the electrode patch from the O^2 Patch.
3. Place the new electrode patch on the O^2 Patch.

7.3 Changing the battery

Danger of poisoning and suffocation!

Children could swallow batteries. Keep batteries out of reach of children.

Do not throw batteries into fire.

Only insert into the O^2 Patch batteries in compliance with the specifications listed in the "Technical Data" section

Do not attempt to recharge the batteries!

Change the battery as described in the "Inserting the battery" section.

8. In case problems occur

Problem	Possible Cause	Solution
The O2Patch is switched on, but does not function.	The battery is not inserted.	Insert the battery.
	The battery is empty.	Replace the battery.
	The O2Patch is defective.	Mail your O2Patch to our service department, see Service and Warranty. or Disposal of the O2Patch, see Disposal and Environmental Protection
The stimulation is too weak.	The battery is low.	Replace the battery.
The patch does not adhere any longer.	The patch is dried out.	Replace the patch.

9. Technical Data

Manufacturer:

Well-Life Healthcare Limited
1FI., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Type of device:

Device for transcutaneous electrical nerve stimulation (TENS)

Classification according to 93/42/EWG:

Class Ila

Model Description:

WL-2405

Maximum permissible ambient temperature:

10^ - 45^

Maximum permissible relative humidity:

30% - 75%

Maximum permissible air pressure:

700 hPa - 1060 hPa

Battery:

Coin cell type CR2032, 3 V, non-rechargeable

Max. output of electrodes: 50mA

Pulse width: 100 - 150 μs

Pulse rate: 10 Hz - 20 Hz

Operating voltage: 3 V

Weight: 10 g (w/o Battery)

Dimensions (mm): W:55 x D:10 x H:140

10. Service and Warranty

10.1 Service Addresses

England:

International Business Products Limited

6 Newfield Court

West Houghton

Bolton BL5 3 SA England

Phone: [phone] - 8196 95

India:

sano health care products pvt. Ltd.-Group

Corporate Office:

28 Landsdown Terrace

1st Floor

Kolkata - 700 026

Phone: [phone]

10.2 Warranty and Compensation for

Damages

Starting with the purchase date (date on proof of purchase or receipt) we will perform repairs free of charge for 24 months, should your device be non-operational due to manufacturing or material defects.

The warranty excludes damage resulting from non-compliance or only partial compliance with these instructions for use.

Farther-reaching claims such as compensation for damages are likewise excluded.

Please send your device in question as well as the proof of purchase or receipt and the description of the complaint to our service address.

Please also attach the warranty documents if you would like to file a warranty claim.

Batteries and electrodes are excluded from the warranty.

11. Disposal and Environmental Protection

11.1 Battery disposal / battery safety instructions

Do not dispose of used batteries in domestic waste, but instead in hazardous waste or take them to a battery collection site available at your retailer.

Battery safety instructions:

Do not short-circuit battery
Do not throw battery into fire

Explosion Hazard

Your retailer will answer additional questions regarding disposal.

12. What does the designation on your product mean?

The name plate is located on the bottom of the O^2 Patch.

ibp

GmbH Jena, Germany

O2 Patch TENS

Model(I):WL-2405*Art.-No.:10154

Batterie/Battery: 3V CR2032

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

serial number

At the end of its life cycle, this product must not be disposed of in regular domestic waste, but must be taken to a collection site for recycling electric and electronic devices (disposal of used appliances).

Type BF application device The application device offers protection against electrical shock by standard compliance to leakage currents (Type B). The application device is insulated (Type F).

Follow instructions for use

C

The product meets the safety requirements of EU guideline 93/42/EWG

Well-Life Healthcare Limited
1Fl., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Type d'appareil :

Dimensions (mm): B:55 x T:10 x H:140

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

Numero de série

Well-Life Healthcare Limited
1Fl., No. 16Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, R.O.C

Apparaattype:

Well-Life Healthcare Limited
1Fl., No. 16 Lane 454, Jungjeng Rd.
Yunghe City, Taipei City
Taiwan, Républca de China

Tipodequipment:

Hersteller/Manufacturer:

Well-Life Healthcare Ltd., Taiwan

S/N:

S/N

Numero de série

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